Udi in brazil.
ANVISA released the UDI regulation establishing a UDI system applying to medical devices placed on the Brazilian’s market, entering into force on 10 January 2022.
The regulator plans a six-year rollout of UDI requirements according to risk class. This Resolution applies to all medical devices regulated by Anvisa, except for custom-made medical devices and medical devices under clinical investigation.
GS1 has been accredited by ANVISA as issuing agency for unique device identifiers (UDIs).
The requirements are aligned with the IMDRF framework.
ANVISA - RESOLUÇÃO DE DIRETORIA COLEGIADA - RDC Nº 591, DE 21 DE DEZEMBRO DE 2021
GS1 Brasil Healthcare webpage
GS1 Brasil folder on UDI
The Rules for Unique Identification System for Medical Devices (hereinafter referred to as the Rules), released in August 2019 by China National Medical Products Administration (NMPA), has ushered in the stepwise implementation of Unique Identification system for medical devices.
GS1 China is a qualified issuing agency for UDI in China and GS1 standards meet the NMPA’s criteria for issuing UDIs. GS1 Member Organisations across the world will help manufacturers implement with the requirements of the NMPA UDI regulation, to support patient safety and supply chain security.
On October 14, 2019, NMPA issued the Announcement on Effective Implementation of Unique Identification for the First Batch of Medical Devices (hereinafter referred to as the Announcement), which clearly defines the scope, schedule and work requirements of unique identification for the first batch of medical devices. As per the Announcement, for medical devices listed in the first batch, the registrant shall follow the Rules, timely, orderly and effectively perform the coding of Unique Identification, and complete the submission of the registration system and database for unique identification .
On September 29, 2020, NMPA, National Health Commission and National Healthcare Security Administration issued the Announcement on Further Promoting the Pilot and Effective Implementation of Unique Identification for the First Batch of Medical Devices which extended the scope and redefined the schedule.
On September 13, 2021, NMPA, NHC and NHSA issued the Announcement on Effective Implementation of Unique Identification for the Second Batch of Medical Devices .
On February 10, 2022, NMPA, NHC and NHSA issued the Announcement on Effective Implementation of Unique Identification for the Third Batch of Medical Devices .
English version of the Rules for Unique Device Identification System
NMPA published 5 related standards which can be found here
GS1 China UDI webpage for UDI guidance and FAQ
GS1 China Quick Guide for NMPA UDID GDSN Testing
GS1 China Filling Procedures of GS1 Company Prefix (GCP) / Global Trade Item Numbers (GTINs)
Taiwan has begun a phased implementation of UDI, which includes both labelling and database reporting requirements. The “ Requirements for Indicating the Unique Device Identifier on Medical Device Labels " came into force on 1 May 2021. Issuing agencies include GS1, HIBCC and ICCBBA.
The EU Medical Device Regulation (MDR) and In-vitro Diagnostic Regulation (IVDR) were adopted on 5 April 2017 and define the requirements for the EU UDI system.
On 7 June 2019, GS1 was designated by the European Commission as an issuing entity for Unique Device Identifiers (UDIs). GS1 standards are enabling healthcare manufacturers from around the world to create and maintain UDI numbers by following the EU Regulations and the GS1 General Specifications .
Required product data will be submitted to EUDAMED, i.e. the EU regulatory database for regulated medical devices .
The EU Regulations have introduced a new concept: the Basic UDI-DI, that aims at grouping regulated medical devices under the same identifier. GS1 has developed a new key to support the implementation of the Basic UDI-DI: the Global Model Number (GMN) . The GMN generator tool helps generate the GMN (Basic UDI-DI), calculate the related check character pair or verify your GMN (Basic UDI-DI).
The European Commission submitted a work request to GS1 to develop a Master UDI-DI for implementation of a new level of identification for specific products. For more information, and to join the Global Standards Management Process Mission Specific Work Group (GSMP MSWG) see the Call to Action .
Compliance dates for UDI requirements and complementary information by type of actor in the EU are available in the European Commission’s website in the section “Getting ready for the new regulations” .
The European Commission is working on implementation details and is regularly publishing complementary guidances and MDCG endorsed documents , including Q&As and proving guidance on specific device types and assignment rules.
European Commission UDI Helpdesk
European Commission webpage on Medical Devices
European Commission FAQ on UDI
European Commission MDCG endorsed documents and other guidance
European Commission Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 amending Reuglations (EU) 2017//745 and (EU) 2017/746
GS1 UDI identifier Basic UDI-DI (video)
GS1 brochure “Be ready for UDI in Europe!”
GS1 Global Model Number (GMN) generator
GS1 Position Paper on Global Model Number (GMN) management guidance regarding mergers and acquisitions
GS1 Call to Action: New EU requirements for medical devices identification (i.e. “Master UDI-DI”)
MedTech Europe Guidance on Basic UDI-DI assignment
According to the President of the Egyptian Drug Authority’s Decree number (499) of the Year 2021, "Medical Supplies factories, companies, distributors, importers, and warehouses with all of its types and sources that deal in the Egyptian market are committed to using the Global trade items barcode (GTIN) for all medical supplies that are being traded inside the local market, through dealing with the electronic platform (Me Device)".
According to the Guidance on Requirements for Unique Device Identification (UDI) for Medical Devices, "In case the medical device is encoded with any other issuing agencies designed by the IMDRF, the brand owner / Agent should submit a request to EDA reporting them about the issuing agency they adopted".
The President of the Egyptian Drug Authority’s Decree Number (499) of the Year 2021 (AR)
Guidance on Requirements for Unique Device Identification (UDI) for medical devices
The SFDA UDI regulation was enacted on 1 August 2021, and GS1 has been accredited as issuing agency. The database, SAUDI-DI, aims to document unique device codes for medical devices based on accredited international standards, allowing all stakeholders to identify medical device information through the unique device identification code registered in the system.
Manufacturers and their authorised representatives are directly responsible for providing all data of unique device identification codes for their medical devices.
Saudi_DI is available since 1 October 2020.
The UDI regulations in Saudi Arabia cover all medical devices distributed in the KSA market and manufacturers, except for custom-made devices and investigational medical devices. The SFDA guidance outlines the main requirements for the unique identification system to be applied for medical devices allowed to be imported and marketed in Saudi Arabia.
Requirements for Unique Device Identification (UDI) for Medical Devices
SAUDI-DI website
The Health Sciences Authority (HSA) in Singapore released the final UDI Guidance . The purpose of the guidance is to provide clarity on the regulatory requirements for Unique Device Identification (UDI) implementation in Singapore and the details on the steps to submit UDI information into the Singapore Medical Device Register (SMDR) and Class A Medical Device Database. The fundamental elements of the UDI system in Singapore are in alignment with the internationally harmonised principles published by the International Medical Device Regulators Forum (IMDRF).
GS1 has been accredited by the HSA as issuing agency for unique device identifiers (UDIs).
Devices identified and marked according to the UDI requirements for the U.S. & the EU will be accepted by HSA. The UDI-DI will be registered in the Singapore Medical Device Register (SMDR), an online database.
HSA medical devices dedicated page
HSA FAQ on Medical Devices System
HSA UDI-DI submission video for registered medical devices
GS1 Singapore webpage on Unique Device Identification
Following the publication in 2028 of notification No. 2020-29, the UDI barcode labelling obligation came into force in 2020 for Class IV devices. Requirements aligned with the IMDRF framework in which South Korea is participating.
In 2022 UDI has been fully implemented with all classes of medical devices requiring a Unique Device Identifier.
The Ministry of Food and Drug Safety (MFDS) has implemented Unique Device Identifier (UDI) database systems for submitting regulatory-mandated medical device product data. The database is called Integrated Medical Device Information System (IMDIS). The National IMDIS collects both medical device data and medical devices’ distribution (transaction) records.
GS1 has been accredited by Korean Authorities as issuing agency for Unique Device Identification (UDI).
MFDS website on medical devices
NIDS Data Submission guidelines
NIDS Guidelines for generating UDIs
In Türkiye, medical devices are regulated by the Turkish Medicines and Medical Devices Agency (TİTCK). The Unique Device Identification (UDI) requirements follow the guidelines of the European Union Medical Device Regulation (EU MDR). GS1 is an accredited issuing agency in Türkiye.
The UDI requirements for medical devices in Türkiye include:
Ürün Takip Sistemi-Product Tracking System (ÜTS)
In 2013, the U.S. Food and Drug Administration (U.S. FDA) released the UDI rule . The FDA established the unique device identification system to adequately identify medical devices sold in the United States from manufacturing through distribution to patient use.
According to the U.S. FDA , when fully implemented, the label of most devices will include a unique device identifier (UDI) in human- and machine-readable form, which will ultimately improve patient safety, modernise device postmarket surveillance, and facilitate medical device innovation.
In general, the UDI final rule requires device labelers (typically, the manufacturer) to:
Since 17 December 2013, GS1 has been accredited by the U.S. FDA as an issuing agency for Unique Device Identification (UDI).
U.S. FDA UDI system dedicated webpage U.S. FDA UDI Compliance Policies and UDI Rule Compliance Dates U.S. FDA - UDI Rule, Guidances, Training and Other Resources
U.S. FDA UDI Help Desk
US FDA - Classify Your Medical Device GS1 US webpage on Unique Device Identification
GS1 US Implementation Guideline – Applying the GS1 System of Standards for US FDA Unique Device Identification (UDI)
GS1 US Healthcare Supplier FDA UDI Quick Start Guide
Identification of medical devices containing an HCT/P in the United States. Recommendation for labelling Issued by ICCBBA and GS1.
Preparing an immigration application for U.S. Citizenship and Immigration Services (USCIS) requires filling out complex paperwork and gathering supporting documents. Using a cover letter is a great way to keep your application materials organized and make sure you don’t miss any required documents. It’s also a good opportunity to highlight anything you want USCIS to know about your application. This article explains what a cover letter is and the elements it should include. It also includes a template you can use to write your own.
Written by Jonathan Petts . Updated May 4, 2023
A cover letter is a document that helps USCIS officers navigate your application materials. You can place a cover letter at the top of your citizenship , permanent resident , DACA , or visa application package. By outlining your reasons for applying and the contents of your application in a cover letter, you give your USCIS officer a useful overview of your case. You can also use your cover letter as a personal checklist to make sure you’ve included all necessary documents in your package.
You may also use a cover letter to explain any special circumstances you want the USCIS officer to be aware of before they start reviewing your application. If you have a unique or complicated background, it is especially helpful to supplement your application with a cover letter. It will ensure that USCIS becomes aware of any special circumstances and can consider your application with this in mind.
USCIS does not require you to submit a cover letter for any immigration benefit or visa application. Many immigration attorneys include cover letters for their clients to prevent any misunderstandings or missing paperwork. Immigration officers read through a lot of paperwork, so any guidance or organization you can offer them will be helpful.
Cover letters may be especially helpful when you are in a unique situation. Suppose you are applying for a marriage green card with Form I-130 : Petition for Alien Relative, and you and your spouse have lived apart for some time. You and your U.S. citizen or green card holder spouse can use a cover letter to explain this or any other unusual circumstances behind your marriage.
USCIS will want to know the reasons behind an unusual living or marriage situation when evaluating your adjustment of status application. A cover letter can help you address any major concerns at the beginning of the process.
When submitting a cover letter with your application, be sure to include the following:
The USCIS filing location or lockbox address to which you’re sending your application
The date of filing
An appropriate subject (re:) line
A short introductory paragraph to describe the contents of your letter and package
If applying for a marriage-related benefit, information about the marriage date and location for yourself (the beneficiary) and your spouse (the petitioner)
An ordered list of the content in your application package, including all supporting documents and filing or biometrics fees included
A closing paragraph including your contact information
Your signature and full printed name
Your supporting documents for an application will depend on which forms you’re filing. You can determine which documents are necessary by reviewing USCIS’ webpage for your specific form. For example, USCIS lists the required supporting evidence on its webpage for Form N-400 applicants.
You’ll also need to identify the right mailing address for your application. To do so, you should consult the USCIS website. For example, naturalization applicants can review USCIS’s webpage for Form N-400 direct filing addresses .
Your filing fees will depend on your specific application type. You can use the USCIS Fee Calculator to determine your costs. For example, suppose you are filing for naturalization with Form N-400. You should select Form N-400 on the Fee Calculator and enter your age. USCIS may ask for additional information, such as your specific application category.
You may use the sample cover letter below as guidance when writing your cover letter. This specific cover letter sample is for a naturalization application, intended for submission alongside Form N-400. Be sure to personalize this template to reflect your application type and circumstances. If you’d like to use the following template, you may also make a copy of this document to start writing.
[Petitioner’s Street Address]
[Petitioner’s City, State ZIP code]
[Relevant USCIS mailing address]
RE: [Naturalization Application]
Beneficiary: [Immigrant’s Full Legal Name]
To Whom It May Concern:
Enclosed, please find the Naturalization Application for [Immigrant’s Full Legal Name].
The following documents accompany and support this application:
Filing Fee Payments
[Check or Money Order] in the amount of [Current Fee Amount] for Form N-400
Form G-1450 authorizing payment of the filing fee for Form N-400 (credit card charge authorization if you completed one)
[Form G-1145 (e-notice authorization if you requested them in our system)]
[OPTIONAL Beneficiary’s Form I-912 Fee Waiver Application]
[List of supporting documents]
Beneficiary’s Form N-400 Application for Naturalization
If you have any questions or concerns, please call me at [Phone Number]. Thank you very much for your prompt consideration of my Naturalization Application.
[Immigrant’s Full Name]
[Immigrant’s Signature]
[Signature Date]
When writing a USCIS cover letter, be sure to type your letter in English on a computer. Keep your letter concise and only include necessary information. A long cover letter will not be as helpful to a USCIS officer as a brief letter. If possible, keep your letter to one page. Be sure to proofread your letter before submitting your application package.
Continue reading and learning!
Jobscan > Cover Letter Writing Guide
Here’s a comprehensive guide on how to write a cover letter that will get you noticed by recruiters.
Trusted by:
A survey revealed that 77% of recruiters prefer candidates who send in a cover letter, even if submitting it is optional. Additionally, 90% of executives consider cover letters invaluable when assessing job candidates.
So, if you think cover letters are no longer important and necessary in 2024, think again.
Here’s a comprehensive guide to help you write a cover letter that effectively sells your skills and professional experience, increases your chances of getting interviews, and gets your foot in the door.
Table of Contents
A cover letter is a letter of introduction accompanying your resume that paints why you are the best person for the job, what you bring to the table, and how you can help move the company forward.
Is the cover letter dead? No! In fact, a recent study by ResumeLab revealed that 64% of job vacancies still require that you include a cover letter in your application and 83% of HR pros said that cover letters are important for their hiring decision.
The bottom line is that a cover letter is still a valuable piece of your job search collateral. Nail your cover letter and you could end up getting that dream job.
So what exactly do you need to accomplish in your cover letter?
According to 49% of HR managers , your cover letter is the second best way to call attention to your resume and distinguish yourself from other applicants.
So the main purpose of your cover letter is to compel the recruiter to read more about you on your resume and move you to the next part of the hiring process.
Further, according to award-winning resume expert Melanie Denny , your cover letter is your value proposition letter. It proves why you are the best candidate to address the company’s needs with the professional skills and qualifications to succeed in the job.
Here’s an example of a great cover letter:
Now let’s get into the details of what your cover letter needs to include.
Here’s a quick rundown of what you need to include in your cover letter.
Here’s an example for the visual learners out there:
Now that you know the basics of what to include in your cover letter, let’s go through the process from start to finish to see how you can write a cover letter that will make you stand out from the rest of the candidates.
It can be intimidating to try to parse down all your best qualities into a few quick paragraphs for your cover letter.
Here are 9 steps you can take to make sure you’re headed in the right direction:
Before writing your cover letter, thoroughly read the job description and the requirements for the job.
Melanie Denny , award-winning resume expert, likens the job description to your cover letter cheat sheet. And when checking the job description, she says you need to consider the following:
This will help you customize your cover letter, angle yourself and your narrative to fit the role better, and impress the hiring manager.
Try reaching out to the recruiter, hiring manager, or someone working in the company if you want more in-depth information about the company and the position you are applying for.
Make sure your cover letter matches the job you are applying for. Writing a generic cover letter is a missed opportunity as this will not appeal to the recruiter or hiring manager. According to research from ResumeGo , 81% of HR professionals value job-specific cover letters over generic ones. Jobseekers who had tailored cover letters received a 53% higher callback rate compared to those who had no cover letter.
Remember, your cover letter is your chance to prove that you are passionate about working for a given company, so take the time to write a tailored cover letter for each position . You can do this by mentioning your skills and experience that are directly related to what’s mentioned in the job description. If you’re applying for a data analyst role that requires expertise in Microsoft Power BI, cite an example of a Power BI dashboard you built and how it helped the company.
Read our full guide: How to Optimize Your Cover Letter
You should make it easy for the hiring manager to reach you. In your cover letter, list these three things:
Traditionally, your contact information is included in the upper left corner of your cover letter if you’re writing in a document. If you’re writing an email, this can be included beneath your signature at the end of the message.
Jane Jobscan Seattle, WA 98101 (555) 555-5555 • [email protected] linkedin.com/in/jane-jobscan
February 25, 2024
Lavinia Smith Hiring Manager Media Raven, Inc. Plantersville, MS 38862
According to Melanie Denny, resume expert and President of Resume-Evolution, addressing your cover letter to a real person and addressing them by their name feels more personal and shows recruiters and hiring managers that you took time and did the research.
You can usually find the hiring manager’s name by searching the company website or LinkedIn profile, or by calling the company and asking which hiring manager is assigned to the particular position.
Once you learn the name, a simple greeting of “John” or “Hello John” is all you need.
If you can’t find the hiring manager’s name, you can use any of the following:
Read our full guide: How to Address a Cover Letter
Melanie Denny suggests that you start your cover letter with a bang. This will hook the hiring manager’s interest and show them how you can be a valuable addition to the team.
Here are things you can do:
For example,
“I want to bring the marketing department of Media Raven Inc. to the next level and help the company exceed goals and reach more customers as Marketing Manager.”
Take advantage of this real estate and prove to the prospective employer how your background, values, and professional experiences position you as the best fit for what the role requires.
This is especially important if you are switching careers. Highlight your relevant accomplishments in your cover letter, showcase your transferable skills, and explain how you can help the company address its challenges and succeed.
For example:
“As the Director of Marketing at ABC Company since 2018, I directed all phases of both the creative and technical elements of marketing initiatives, including data mining, brand creation, print/web collateral development, lead generation, channel partner cultivation, customer segmentation/profiling, as well as CRM and acquisition strategies.
Perhaps most importantly, I offer a history of proven results, as evidenced by the following marketing accomplishments for my current employer:
Just like when writing a resume, your cover letter should only include the most relevant and positive information about you. To home in on the right skills and qualifications to mention, try scanning your cover letter .
Read our full guide: What Do You Put in a Cover Letter?
Use the closing of your cover letter to:
Keep the closing professional and try not to sound too eager since that can come off as desperate. You must also keep in mind the tone and personality of the company you’re communicating with.
“Given the opportunity, I’m confident I can achieve similar groundbreaking marketing results for Media Raven, Inc.
Ms. Smith, I would welcome the chance to discuss your marketing objectives and how I can help you attain them. Feel free to call me at (555) 555-5555 or email me at [email protected] to arrange a meeting. I look forward to speaking with you.”
Read our full guide: How to End a Cover Letter With a Call to Action
To finish out the closing , use a formal signature. You can use “Sincerely,” “Best,” “Regards,” “Yours,” or any other professional signoff.
Use your first and last name as your signature. If you’re sending your cover letter in the body of an email, make sure it’s your personal email account that does not list your current work signature beneath the email. Your other option is to write the cover letter in a word document, save it as a PDF, and attach it to your email.
The Applicant Tracking System or the ATS is a software that companies use to screen applications and shrink their pool of applicants. Through the ATS database, a recruiter or hiring manager can just search for specific skills and keywords and the ATS will return a list of the top candidates who match the search criteria.
To optimize your cover letter for ATS, you need to:
Read our full guide: How to Optimize Your Cover Letter to Beat the ATS
Does your cover letter pass the test?
Scan your cover letter to see how well it matches the job you're applying for. Optimize your cover letter and resume with Jobscan to get more interviews.
A cover letter is a letter, but that doesn’t mean you should just plop everything onto the page in a stream-of-consciousness flow. After all, cover letter formats determine the order in which the hiring manager learns about you, which can significantly influence their first impression. Use the format order below as a guideline for building the structure of your cover letter.
Notice how the topics flow like a conversation? When you first meet someone, you introduce yourself, tell them your name and a little about yourself, and then leave the conversation open for future meetings.
Your cover letter is just a like having a conversation with someone for the first time. Keeping that in mind will help you to keep things simple and focus on the right information.
Below are some examples of how to format your cover letter for different types of applications.
You can also check out our cover letter templates to help you as you write your own cover letter.
Do you want to save time and receive instant feedback on your cover letter? Check out Jobscan’s cover letter tool .
Read more : How to Write a Resume for Today’s Job Market
Cover Letter Examples
Here are some examples to help you create a cover letter that will make you stand out and give a strong first impression.
Aside from the basic steps of how to write a cover letter, there are some things you definitely need to make sure you avoid – and things you can’t skip! Follow these do’s and don’ts for writing a cover letter, and you’ll end up with a much better result.
In addition to resume scans, Jobscan Premium users can also scan their cover letters against a job description.
This generates a report of the top hard skills and soft skills found in the job description that should be included in your cover letter, plus additional checks for optimal length, contact information, measurable results, and more.
Here’s how it works:
Your cover letter gives recruiters, hiring managers, and prospective employers an overview of your professional qualifications and relevant accomplishments that position you as the best candidate for the job.
So you have to make your cover letter powerful and interesting enough to make the recruiter or hiring manager read your resume and move you to the next step of the hiring process.
Here are key pointers when writing your cover letter.
Having a strong cover letter is not enough. You also need to create a killer resume to make sure you stand out and land job interviews.
Frequently asked questions, what are the different types of cover letters.
There are four types of cover letters.
It can be appropriate to change tenses throughout your cover letter.
For example, you can explain who you are in the present tense and explain important aspects of your work history in the past tense. You can switch to future perfect tense when discussing the ways you would perform if given the position.
Think of it like this, “I am ABC, I did XYZ previously, and I look forward to doing EFG in this position.”
Our cover letter guidelines above explain how to write a cover letter more deeply, but in summary, you should always include your name, relevant work experience, and reasons why you are right for the job in your cover letter.
Typically, your cover letter and resume will be sent as a pair, but your cover letter is meant to be an introduction to your resume. If it is an email, use the cover letter in the body and attach your resume, otherwise, attach both.
Pro Tip: Be sure to review all instructions in the job description to follow the hiring manager’s requests.
According to 70% of recruiters, a cover letter should not exceed 250 to 300 words.
Although there is no hard and fast rule about this, the ideal cover letter length should be around half a page to one full page in length to keep your message concise, clear, and easy to digest.
If it is not specified in the job posting, a cover letter can be sent either as an attachment (PDF is best) or in the body of an application email with your resume attached.
There are several methods of sharing a cover letter with potential employers, depending on their application process.
Cover letters can be written on a document and turned into a PDF to be uploaded to a job application website or attached to an email along with your resume.
In other cases, your cover letter can simply be written in the email message to a hiring manager, with your resume attached.
The key in every aspect of job applications is to make yourself an easy “yes” for your potential employer. That means making it easy for the hiring manager to keep track of your application materials for later review. With this in mind, make sure your full name and the phrase “cover letter” are included in the file label. Other helpful details might include the job title you’re applying for or the year of your application.
Here are a few examples:
Explore more cover letter resources
Cover Letter Formats
ATS-Optimized Cover Letter
Cover Letter Templates
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June 28, 2022 by t_king
A UDI is a unique numeric or alphanumeric code, that is placed on medical devices to identify them. This identifier must be provided in two forms on labels and packages-plain text and machine-readable. The purpose of a UDI is to improve the accuracy and completeness of adverse event reporting, product recalls, and other safety-related activities.
It will also help patients, providers, and payers better track medical devices throughout their life cycle.
The FDA is responsible for issuing regulations on the use of UDIs, and they have established a UDI rulemaking process to develop these regulations. In September 2013, the FDA released a proposed rule that would require most medical devices to bear a UDI.
The implementation of UDIs has been phased in over a period of years, with different timelines for different types of devices. Class III devices, which are those that support or sustain human life, were required to have UDIs by September 24, 2016. Class II devices, which are those that pose a moderate risk to the patient, were required to have UDIs by September 24, 2018. And Class I devices, which are low-risk devices, must have UDIs by September 24, 2020, even though the FDA will not enforce Class I UDI labeling before September 24, 2022.
So what does this mean for you? If you are a manufacturer of medical devices, you will need to comply with the UDI regulations when they are finalized. This may require changes to your labeling and packaging processes. You will also need to register your devices in the FDA’s Global Unique Device Identification Database (GUDID) and submit data about your devices on a regular basis.
UDIs have the potential to improve patient safety and reduce costs throughout the healthcare system. We encourage you to stay informed about the UDI rulemaking process and how it may affect you.
For more information on how Compliance Insight can help your company with the UDI process, please visit our website at www.compliance-insight.com
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It’s no easy task to know how to write a cover letter for engineering.
Writing a cover letter for engineering needs to include your skills, accomplishments, and most importantly, your macroeconomic relevance.
The framework that we use in our cover letters breaks it down in four sections:
In a select few cases, the recruiter or hiring manager will actually want a cover letter.
There are cases when having a cover letter puts you above the person that didn’t in their job application.
When you have a cover letter that
Highlights your skills and accomplishments
Clearly and concisely lists what you’re looking for
Ties your macroeconomic relevance to the position
Your recruiter will have a much better understanding of you as a candidate and understand your specific business impact.
Also, keep in mind the reason that you’re looking for a job. Take this seriously.
You could want a job for more pay or you need this job so that you can put food on the table and feed your family.
And when you’re looking for a job, you want to maximize the chances of you getting that job.
In no case, will having a cover letter hurt your chances of getting a job.
Worst case scenario is that the recruiter or hiring manger doesn’t even read the cover letter.
Advancing in your career is nothing you should be taking lightly. Neither does having to put yourself in a position that you’re responsible for the well being of yourself and others.
The introductory paragraph of your engineering cover letter must:
Thank the hiring manager for the opportunity to apply
Tie in your skills and accomplishments to the engineering position
Detail how your skills will benefit the company
Tie in your position’s relevance to macroeconomics
One of the biggest mistakes engineers make in their cover letters is that they mention how much they want the position or how the position will aid in their growth and development.
Although this isn’t bad, it is much better to frame the letter in a manner such that the company will benefit from you.
The company does not care about what you can get. Ultimately, the company is looking to make money and turn profits. As a result, a company needs to increase their revenue, streamline processes, and cut costs. You need to be able to fit somewhere in that equation.
The second paragraph of your engineering cover letter will detail your high level accomplishments and their ties to the applications/industries in macroeconomics.
Residential
Oil & Gas
Agricultural
Transportation
Food & Beverage
Pulp & Paper
The engineering position that you are applying for likely has ties to these applications and industries. Make sure you connect the dots between the industries and your position as this presents you more as a business case.
If you frame yourself as a business asset in the cover letter (and your resume), you will be much more of an attractive asset that employers will seek out. Hiring managers are required to set goals and these goals that they set pertain to company financials and their ties to macroeconomics.
Now do you understand the importance of macroeconomics in your career search framework?
Your third paragraph will detail your current role and what you’ve been able to accomplish.
Do not include boring items such as:
Created excel spreadsheets for this
Typed up documentation for XXX
Kept track of inventory of parts
Instead capture the big picture overview of what your tasks supported.
For example, if you do alot of client interface, don’t say that you do calls or emailing clients, but say that you do client interfacing roles to support manufacturing revenue of $/year.
Make sure you also tie in how you want to grow and develop as an engineer, which reinforces your reasoning for looking for this position. Again, this also frames you as a business asset, which is the framework that we are applying in this cover letter.
Reiterate how your skillset and knowledge will benefit the company and relevance to the industry/application that the company supports (business case and macroeconomics framework)
Specify core competencies such as your leadership skills and innovativeness and finish the letter off by stating that you want to support the company’s mission and sustain their dominant position in the market as a leader.
Now that we’ve detailed how to write a cover letter for engineering, let’s check this example out.
Dear Hiring Manager,
Thank you for your consideration.
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This is the exact engineering cover letter framework that I use to get hundreds of my clients high paying jobs.
Steven Nelson
Some of the 51 “Spies Who Lie” were active CIA contractors when they claimed files from first son Hunter Biden’s laptop had “the classic earmarks” of Russian disinformation ahead of the 2020 election — a fact that was uneasily noted inside the agency at the time, new records acquired by The Post show.
Former CIA acting director Michael Morell, who previously told Congress he organized the Oct. 19, 2020 , letter to give Joe Biden a “talking point” ahead of a debate against then-President Donald Trump, was a contractor at the time, the agency recently confirmed to Congress.
Former CIA inspector general David Buckley also was a contractor at the time of the letter, according to an interim report from two House committees investigating the matter.
The terms of their contracts and compensation were not immediately clear and the House panels believe additional letter-signers may have been contractors — even though the letter described the signers as “former” officeholders.
“This frustrates me. I don’t think it is helpful to the Agency in the long run,” a CIA official whose identity was redacted wrote on Oct. 20, 2020 — the day after the letter was distributed to Politico — with a link to the outlet’s story.
“I also love that at least a few of the random signatures belong to individuals currently working here on contracts…,” responded another official, whose name also was redacted.
The federal Hatch Act bars most employees of the CIA and other spy agencies from engaging in partisan political activity, but the status of contractors is murkier.
The CIA indicated Morell and Buckley were contractors in a table which specified that former CIA director John Brennan and fellow letter-signers Nick Rasmussen and Marc Polymeropoulos had no such arrangement.
A separate agency-provided table showing officials who had either badge clearance or contracts at the time suggests that other signers had formal relationships with The Company.
That table also indicates that Morell’s contract lapsed at some point after Oct. 19, 2020, and that he entered into a new contract on May 1, 2021, as an “independent contractor” — though that relationship was qualified as including “no fee senior advisory services,” making the financial component unclear.
Morell’s colleague at Beacon Global Strategies, fellow letter-signer Jeremy Bash, is identified in the second table as an “independent contractor” as well — serving as a “contractor/green badge” holder from April 2, 2019, through April 1, 2022, with a brief gap before receiving a new deal beginning in August 2022.
Another letter-signer, former National Security Agency deputy director, Richard Ledgett, was also listed as having the same status at the time of the letter.
The disclosures are contained within an interim report by the House Intelligence Committee and the House Judiciary Committee’s Subcommittee on the Weaponization of the Federal Government — which also reveals that then-CIA Director Gina Haspel likely knew about the letter when it was submitted for review.
“The new information included in this report, based on new testimony and declassified documents, shows the potential dangers of a politicized intelligence community,” the interim report by the House panels says.
“Some of the signatories of the statement were on the CIA payroll at the time as contractors and others had special access to CIA facilities.
“Even Michael Morell — before the Committees learned of his contract with the CIA — acknowledged, ‘It’s inappropriate for a currently serving staff officer or contractor to be involved in the political process.'”
The report notes that: “Due to purported operational concerns, the CIA declined to declassify the entire universe of signatories who were on active contract.”
Then-candidate Biden used the intelligence alumni letter to falsely claim at his second and final 2020 presidential debate with Trump that The Post’s reporting on his role in his family’s international business dealings was a “Russian plant” and “garbage.”
“There are 50 former national intelligence folks who said that what he’s accusing me of is a Russian plant,” Biden said of Trump. “Five former heads of the CIA, both parties, say what he’s saying is a bunch of garbage. Nobody believes it except his good friend Rudy Giuliani.”
Morell testified to Congress last year that he was inspired to organize the letter after receiving a call from future Secretary of State Antony Blinken, a longtime Biden adviser.
The Post’s first laptop bombshell — published five days before the 51-person letter was made public — revealed that Vadym Pozharskyi, an executive at the Ukrainian gas company Burisma, emailed Hunter in 2015 to thank him for the “opportunity to meet your father” — directly contradicting Biden’s 2019 claim that he’d “never spoken” with his son about “his overseas business dealings.”
The Biden campaign vaguely denied that the meeting occurred . But further reporting corroborated key details, including the fact that Joe Biden attended a 2015 DC dinner one day before the Burisma exec’s email. A group of his son’s associates, including Pozharskyi and a trio from Kazakhstan that posed for a photo with the Bidens, attended.
Hunter earned up to $1 million per year to serve on Burisma’s board from 2014 to 2019, beginning when his father led the Obama administration’s Ukraine policy.
A second October 2020 bombshell from The Post — published four days before the spies’ statement — described communications about Hunter Biden and his uncle Jim Biden’s business venture with the Chinese state-linked company CEFC China Energy, a since-defunct reputed cog in Beijing’s “Belt and Road” foreign influence campaign.
A May 13, 2017, email from the laptop said the “big guy” would get 10% of the CEFC deal and former Biden family associate Rob Walker testified to Congress that Joe Biden met with the company’s chairman Ye Jianming before cash began to flow earlier that year.
The CIA did not immediately respond to a request for comment Tuesday and The Post was not immediately able to reach Morell or Buckley.
Read the full article here .
3 Keys to Writing Cover Letters That Stand Out was originally published on Vault .
It's a myth that high quality job openings are few and far between thanks to Covid. The truth is, despite the economic uncertainty created by the pandemic, there are many great openings out there. And to get them—or, at least, have a chance at getting them—you first need to capture the attention of hiring managers. And the best way to do that is to write compelling cover letters. So here are the three keys to writing cover letters that stand out.
1. Convey your personality, quirks and all.
Showcasing your uniqueness and allowing your personality to shine through in your cover letters can magnetize hiring managers, sending instant messages that you might be the candidate they're looking for. The secret to achieving this is to use specific details, rather than vague ones.
For example, the following was recently used by an applicant when applying for a Head of Marketing position (shortly after sending this, the candidate was interviewed and then hired):
“I have a passion for data and analytics. I enjoy spending (a little too much time) geeking out in Google analytics, advertising platforms, and BI tools (Tableau and Looker), digging deep into data to identify opportunities that can be leveraged to drive growth and inform testing strategies for campaigns, websites, and products.”
Now compare the above to the below (which has less personality and fewer details, and thus would likely not stand out):
“I am well versed in data analytics, and I am experienced with Google analytics, BI Tools, and other advertising platforms. I have a proven ability to inform testing strategies for campaigns for websites and products.”
Here's another example of cover letter phrasing that captures the attention of hiring managers:
“I'm rather obsessed with personal organization. I read three organizational blogs on my own time, and I've organized my desktop folders into color-coded sub-categories. My friends laugh at me for saying things like, ‘An organized space equals an organized mind,' but I don't like wasting time looking for things.”
Now compare that to this less specific phrasing:
“I have a proven track record of being organized, and I have a passion for it. I have a proven knack for keeping files organized on an ongoing basis, and I have put organizational processes and procedures in place for my department. The bottom line is organization is always my highest priority.”
2. Prove your level of dedication to your profession.
Another way to stand out is to illustrate specific things about your dedication to your field. In the following example, a candidate showcases her dedication to her profession, proves that she spends a lot of time thinking about driving results in her field, and shows that she takes concrete steps in order to be a high quality contributor in her field. All of which goes a long way when it comes time for hiring managers to decide which candidates to interview.
“I believe that a good marketing strategy requires seeking out the latest trends and staying one step ahead of the competition. I've attended the Traction conference two years in a row and completed the 2018 Reforge Growth Series, a highly credible and exclusive course that only accepts 10 percent of applicants and is built by leaders from Hubspot, Uber, and other firms. Through these professional developments, I've opened my mind to uncommon marketing methods, and I pride myself on thinking outside the box to develop strategies that create sustainable, low-cost customer acquisition loops that lead to long-term positive ROI.”
Now compare the above to the below, which is less detailed and includes less specific phrasing:
“I have the skills and requirements for this position, and I believe I would complete every task asked of me to the highest standard expected. My background and experience make me an excellent fit for this position for many reasons. I am very interested in marketing, and I think I would be a great asset to the team.”
3. Include concrete, quantitative results that show your value.
In any written application, you'll need to showcase some form of quantitative results to stand out. Note that even if you don't have a lot of shiny results in your career yet (or even any relevant experience—which is okay!), you can still use words to capture someone's attention with what you have done. And if you do have a record of achieving quantifiable results, then by all means include them, like in the below:
“I developed several Google ad campaigns that were worth more than $500,000 and that resulted in high-level customers. Also, through testing and optimization, I increased newsletter sign-ups by more than 200 percent.”
Now compare that to this bland sentence:
“I have experience in Google ad campaigns, as well as experience in testing and optimization.”
A final note
When trying to convey your personality, get across your dedication, or communicate your value, there's a big difference between saying you're a good fit for the job and actually showing it.
So, when writing your cover letters, try to hold these words in mind: I know you (the hiring managers) don't know me, so let me show you exactly why I'm completely invested, committed, and passionate about doing this specific type of work. And let me show you the specific reasons why hiring me, over all other candidates, would be beneficial to you.
If you hold all this in mind, the right details and words will flow right out of you—and into your cover letters.
Natalie Fisher is best known for helping professionals land their ideal roles and achieve explosive salary growth (even with little experience). If you want to dive deeper on the topic of your career mindset and become a person who knows exactly how to land their dream job offer, listen to her on the podcast Get a Six Figure Job You Love .
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In the period from 27 May to 29 May 2024, the police will launch a new queue and appointment booking solution (Timeporten) for the immigration authorities.
The new solution will replace UDI's existing appointment booking solution for appointments with the police. Appointments that have already been booked and registered in UDI's appointment booking system will be transferred to the new solution.
Here you will find important information about the transition to the new queue and appointment booking solution .
How do i create a user account.
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To see your applications, you must log in . Remember to log in in the same way as when you created the application. If you logged in with a username and password, you must log in with the same username that you used when you created the application. If you logged in with ID-porten to register your application, you must log in with ID-porten again to gain access to view and follow up your case.
This means that if you previously used a username and password to register your application, but have now logged in with ID-porten, you will not see your previous applications. You do not need to register a new application. You have to log out of ID-porten and then log in again with your username and password to find your applications.
Even if you have lost access to your account, any applications and information you submitted earlier will still be in our systems.
If you who have sent in an application.
If you have booked an appointment, your booking is still valid. When you booked the appointment, you received an email with a confirmation of the time and date, sent from either '[email protected]' or '[email protected]'. You can search for these addresses in your email account. You will also find a separate email with a list of the documents and the cover letter that you must take with you to your appointment. If you cannot find this email, please check the spam filter.
If you are unable to find the details of your appointment, please contact the meeting point for your appointment: the police, the Service Centre for Foreign Workers (SUA), the embassy or the VFS Application Centre .
If you have already handed in your application documents to the police or a Visa Application Centre, we will process your application as normal, and you will not need to do anything more with your user account. If you have Digipost (eksternt nettsted) , you will receive the decision there. Otherwise, you will receive it by regular post. If you have not yet booked an appointment, you have two choices. You can either contact the meeting point which you selected in your application and ask for an appointment or you can create a new user account and send in a new application. If you paid a fee for your first application, you can contact the meeting point to request a refund.
If you are going to fill in and submit a new application, you can either use a different account if you have access to one or you can create a new account.
If you have received a response to your application and you are going to book an appointment with the police for the purpose of taking a photo for your residence card, you must use the same account that you used when you registered your application from. If you no longer have access to this account, you must contact the police to make an appointment
In the login window , you should always try to click on “Forgotten your password?” and choose a new password, to check if this solves the problem. If your account does not exist anymore, you will get a message which says that there is no account registered with this email address.
There might be different reasons why you have lost access to your account.
I have problems logging in with id-porten. what should i do.
UDI cannot help you with problems related to the ID port. The Norwegian Digitalisation Agency (Digdir) is responsible for this solution. You can find their contact information here. (external website)
No, it is not possible to migrate content from one user account to another. When you log in with ID-porten, this is a new user account in the same way as if you have different user accounts with different e-mail addresses.
Logging in via ID-porten provides extra security that no one else can access the information you have provided in the application form. Another advantage is that you don't have to remember which username and password you used in UDI's application forms.
UDI will in the future launch several services that can simplify the application process for those who have a secure electronic identity.
No. UDI has adopted ID-porten, and we recommend that you use it if you have the possibility. However, you can still log in with the same username and password as before, and create a new user accounted with an email address.
If you log in with ID-porten and apply on behalf of another person, you are the one who must follow up the application until it has been processed. It is you who must book an appointment with the police/SUA and it is you who will receive an answer to the application - not the person on whose behalf you have applied.
No, an employer applying on behalf of an employee should not use ID-porten, and must instead log in with a username and password. This is because it is unfortunate if applications are linked to the personal electronic identity of an individual in the company.
We recommend that you only log in with ID-porten if you are applying for yourself.
However, if you are applying on behalf of a close family member, such as your child, it may be convenient to use ID-porten. In that case, please be aware that you must also follow up the application until it has been processed. This includes, among other things, booking an appointment with the police/SUA for the person you apply for.
In all other cases where you are applying on behalf of others, we recommend that you log in with your username and password and not with ID-porten.
No. Only people with BankID, Commfides or Buypass (Norwegian e-ID) can log in via ID-porten. This is because UDI requires a higher security level (level 4) for logging in with ID-porten than what MinID has (level 3). This is to best secure your personal data.
To use ID-porten to log in at UDI, you must either have a BankID, Commfides or Buypass (Norwegian e-ID).
Read how you can obtain an electronic ID here (external website) .
For help with logging in with ID-porten, you can read more on the webpages of the Norwegian Digitalisation Agency (external website) (Digdir).
How can i find an application submitted before april 2022.
All recent application forms that you have submitted electronically to the UDI can be found on the My applications (external website) page. If you cannot find the application form you submitted before April 2022 in the overview there, this application is in our old application portal. This means that you can no longer find your way back to the application form on our website. If you want to have access to an older case or need to see the application summary of it, you may contact the UDI in writing here .
If you cannot find the application form you submitted before April 2022 in the overview on the My applications (external website) page, this application is in our old application portal. This means that you can no longer book an appointment for this application form digitally. To book an appointment in connection with this application, you must contact the police directly. You will find contact information here (external website) .
To upload documents digitally and submit them to UDI for an application that you submit before April 2022, you can go to UDI's service for submitting documents here (external website) .
Are you submitting an application form on behalf of another person.
Then it is your choice whether you prefer to create a separate user account for this person or whether you want to submit the application from your own user account. We only need the name of the person applying for residence inside the actual application form. However, please note that you may only have one user account per email address.
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All of UDI's application forms, and standard contracts which must be submitted with different types of applications, can be found on this page.
UDI has made checklists explaining which documents you need to hand in. When you apply, you must always hand in a number of supporting documents to the police or embassy. UDI has made checklists explaining which documents you need to hand in. ... signed cover letter from the Application Portal; valid passport; a Statement on study progress (in ...
When you open this document, it should state "Harmonised application form" and have a barcode on the front page. This document must be printed, signed and submitted together with the application instead of the "cover letter". The online application form for a visitor visa must be completed electronically at udi.no.
Application Cover Letter. To apply for a Norway Visa, you initially have to register on the website of the Norwegian Directorate of Immigration (UDI) and complete an online application. Once you do this, you will receive an email with a Cover Letter (as a PDF attachment), which you have to print out and submit with the rest of your documents.
Create new user account. Before you can start filling in your application, you must create a user account. Register your application in the official application portal for people who wish to visit Norway, live in Norway or become Norwegian citizens.
Signed cover letter from UDI's application portal. Two passport-sized photos on white background; Copy of Letter of Admission; Documentation of financing; Housing contract or a letter from OsloMet to the Norwegian Directorate of Immigration (UDI) called "Confirmation to the UDI". This is also your proof of housing. UDI checklist signed and printed
The cover letter allows you to showcase information that can't be found - or isn't clear enough - in the other documents that you'll be handing over to the authorities. It allows you to put forward your travel history in a more detailed manner and, by doing so, helps paint a more complete picture in the mind of the processing officer.
Cover letter from the Application Portal Norway - https://selfservice.udi.no . 2. One (1) photograph glued to cover letter. (biometrical standard, not older than 6 months, 35 x 45 mm.) Invitation (written. 3. in Norwegian or English). The invitation letter must signed by the reference (the one
The UDI regulations in Saudi Arabia cover all medical devices distributed in the KSA market and manufacturers, except for custom-made devices and investigational medical devices. The SFDA guidance outlines the main requirements for the unique identification system to be applied for medical devices allowed to be imported and marketed in Saudi ...
1 Cover letter from Application Portal Norway - https://selfservice.udi.no -signed. .عقوم - https://selfservice.udi.no نم Cover letter/ بلطلا ميدقت باطخ 2 Application form and receipt from Application Portal Norway - signed. .عقوم -https://selfservice.udi.no نم موسرلا عفد لصوو ةرام⅁سلاا ...
Tips for Writing Your USCIS Cover Letter. When writing a USCIS cover letter, be sure to type your letter in English on a computer. Keep your letter concise and only include necessary information. A long cover letter will not be as helpful to a USCIS officer as a brief letter. If possible, keep your letter to one page.
A cover letter is a short introduction to you that concisely communicates your interest in a job opportunity along with your top skills and relevant experience. It's important to customize your cover letter for each role to demonstrate that you've researched the organization's mission and values. — Genevieve Northup, MBA, SHRM-CP, HCI-SPTD.
To send documents to UDI, you must first log in. In the overview of your submitted applications, click on "Upload documents" next to the application you want to upload documents to. This button is only available on submitted applications. When you upload documents, it is important that these are uploaded under the document type they belong to.
Need for a cover letter . Question Hi guys, so I am travelling to Germany some time in September, for tourism. I am Indian currently working in the UK, and was wondering that's despite a cover letter not being mentioned in the required documents list, should I prepare on or not. It just don't want any chance of rejection.
The cover letter is a tool to help introduce yourself in a memorable, personal way during a job application. A well-crafted cover letter goes over information on your resume and expands this information for the reader, taking them on a guided journey of some of your greatest career and life achievements.. Its purpose is to elaborate on the information contained in your resume while infusing ...
Writing a cover letter for engineering needs to include your skills, accomplishments, and most importantly, your macroeconomic relevance. The framework that we use in our cover letters breaks it down in four sections: Why you need to write a cover letter in engineering positions. In a select few cases, the recruiter or hiring manager will ...
A cover letter is a professional document that candidates provide to employers in combination with their resume and other details for a job application. Cover letters act as an extension of your resume and provide employers or hiring managers with more in-depth information about how your qualifications align with the job in question.
The cover letter from udi application portal isn't an any different. Dealing with it using electronic means differs from doing so in the physical world. An eDocument can be viewed as legally binding given that specific requirements are satisfied. They are especially crucial when it comes to signatures and stipulations related to them.
Here are 9 steps you can take to make sure you're headed in the right direction: Step 1. Do your research. Before writing your cover letter, thoroughly read the job description and the requirements for the job. Melanie Denny, award-winning resume expert, likens the job description to your cover letter cheat sheet.
A UDI is a unique numeric or alphanumeric code, that is placed on medical devices to identify them. This identifier must be provided in two forms on labels and packages-plain text and machine-readable. The purpose of a UDI is to improve the accuracy and completeness of adverse event reporting, product recalls, and other safety-related ...
UDI still has all your old applications and information about you stored in our systems. ... You will also find an email with a link to the checklist with the documents you should bring, and an attached cover letter which you must bring to the appointment. If you are handing in a new application, you can use another account you still have ...
Writing a cover letter for engineering needs to include your skills, accomplishments, and most importantly, your macroeconomic relevance. The framework that we use in our cover letters breaks it down in four sections: Why you need to write a cover letter in engineering positions. In a select few cases, the recruiter or hiring manager will ...
Some of the 51 "Spies Who Lie" were active CIA contractors when they claimed files from first son Hunter Biden's laptop had "the classic earmarks" of Russian disinformation ahead of the 2020 election — a fact that was uneasily noted inside the agency at the time, new records acquired by The Post show.. Former CIA acting director Michael Morell, who previously told Congress he ...
Here's another example of cover letter phrasing that captures the attention of hiring managers: "I'm rather obsessed with personal organization. I read three organizational blogs on my own time, and I've organized my desktop folders into color-coded sub-categories. My friends laugh at me for saying things like, 'An organized space equals an ...
When you booked the appointment, you received an email with a confirmation of the time and date, sent from either '[email protected]' or '[email protected]'. You can search for these addresses in your email account. You will also find a separate email with a list of the documents and the cover letter that you must take with you to your appointment.
Before adopting the final rules, the Commission considered more than 24,000 comment letters, including more than 4,500 unique letters, submitted in response to the rules' proposing release issued in March 2022. The adopting release is published on SEC.gov and will be published in the Federal Register. The final rules will become effective 60 ...