The document control procedure and webinar will teach you how to review, edit, and release controlled documents.
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Document Control Procedure (SYS-001) and Webinar Bundle
SYS-001 - Document Control Procedure
This procedure is to ensure that documents within your company’s quality management system are appropriately reviewed, approved and released, and that documents are accessible to those who need to use them.
Price: $299.00
When is the Webinar about this Document Control Procedure?
This webinar will be live on Monday, February 19, 2024 @ 10:30 am ET. The session will also be recorded. You can purchase it on-demand and watch the training as often as you wish.
What you will receive:
Document control lists and forms are also included within this procedure. These documents are updated for the US FDA Quality System Regulation (QMSR), ISO 13485:2016, and the new European Regulations. The following is a list of documents included:
SYS-001 v0.17, Document Control Procedure
FRM-001 v0.3, Document Change Notice
LST-001 v0.29, Master Document List
LST-002 v0.2, DCN List
TMP-001 v0.1, SYS Procedure Template
an invitation to participate in the live webinar (if you purchase prior to February 19)
a recording of the webinar you can replay anytime
the native slide deck for this webinar
If you would like to ask specific questions about the document control procedure and process, please submit them via email or schedule a call using the calendar app on our contact us page.All deliveries of content will be sent via AWeber emails to confirmed subscribers. If you don’t receive the content automatically, please check your spam folder.
Q&A
This document control procedure aims to ensure that documents within your quality management system are appropriately reviewed, approved, released, and accessible to those who need to use them.
The scope of this procedure covers all of the documents that form part of your quality management system. The procedure can be used with both virtual quality systems or an eQMS. You could modify this procedure to work with a Wiki to control documents.
This procedure also applies to all Marketing Communications documents. This includes brochures, website content, flyers, etc..
This is the primary document meeting the applicable regulatory requirements for document control as defined in your Quality System Manual (POL-001).
Please note: This product will be delivered to the email address provided in the shopping cart transaction. After the transaction is verified, please check your email for the download.
To review a sample Medical Device Academy procedure click below:
About Your Instructor
Rob Packard is a regulatory consultant with ~25 years of experience in the medical device, pharmaceutical, and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Rob was a senior manager at several medical device companies—including the President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certifications. From 2009 to 2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Rob’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications, and 510(k) submissions. The most favorite part of his job is training others. He can be reached via phone at +1.802.281.4381 or by email.You can also follow him on YouTube,LinkedIn, or Twitter.
This page explains what you will receive when you purchase our Quality Manual template for ISO 13485:2016, MDSAP, and the EU MDR (POL-001).
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Quality Manual (POL-001) webinar bundle
POL-001 - Quality Manual
POL-001 is our Quality Manual template for an ISO 13485:2016 quality system. This purchase also two additional templates: 1) POL-002, Document Structure ; and 2) POL-003, Glossary. This procedure has been updated for compliance with the MDSAP Regulations, 21 CFR 820, and Regulation (EU) 2017/745.
Price: $599.00
When is the webinar about our Quality Manual template?
This webinar will be live on Monday, March 18, 2024, at 10:30 a.m. ET. It will also be recorded. You can purchase it on-demand and watch the training as often as you wish.
Is a quality manual required?
Unlike ISO 9001:2015, the ISO 13485:2016 standard requires that manufacturers establish a quality manual. This requirement is found in clause 4.2.1(b). POL-001 is Medical Device Academy’s template for a quality manual. It is the primary document meeting the applicable regulatory requirements for a Quality Manual as defined in clause 4.2.2 of ISO 13485:2016. There are four requirements for the content of a quality manual in that sub-clause. First, you must define the scope of the quality management system, including details of and justification for any exclusion or non-application. In ISO 9001:2015, any clause may be excluded. However, ISO 13485 only permits the exclusion of design controls, and sub-clauses within clauses 6, 7, and 8 may be identified as non-applicable depending upon the nature of the products or services. Second, the quality manual must include documented procedures for the quality management system or references to them. Third, a description of the interaction between the processes of the quality management system. Finally, the fourth requirement is that the quality manual outline the documentation structure used in the quality management system.
To address sub-clause 4.2.2a), we included a list of the most common sub-clauses that are identified as non-applicable. In addition, in the manual sections where those sub-clauses are found, we have inserted a draft rationale for non-applicability. In both places, this content is in green font. If the sub-clause does not apply to your device, then you delete that section of the manual’s content and change the green text to the black font. If the sub-clause is applicable, then you delete the sub-clause from the list of sub-clauses that are not applicable. You also delete the draft rationale for non-applicability from the appropriate section of the manual.
To address sub-clause 4.2.2b), we included references to our standard operating procedures in each manual section where the procedure requirement is found. If you only purchase our quality manual template, you must substitute your procedure numbers for the numbers we used. Your firm is outsourcing in any section where the clause applies to your device but is a function. You will need to state this in the manual, and you will need to reference the supplier quality management procedure (i.e., SYS-011) instead.
To address sub-clause 4.2.2c), we included a process interaction diagram at the end of the manual. You will need to update this diagram to remove any procedures that are not applicable. Alternatively, you can replace our generic process interaction diagram with a process interaction diagram of your design.
Finally, to address sub-clause 4.2.2d), we added a pyramid diagram. Corporate policies like the quality manual are at the top of the pyramid. This is also where your policy for risk acceptability would be for the company (see ISO/TR 24971:2020, Annex C.2 and ISO 14971:2019, Clause 4.2.2). The quality system procedures (i.e. SYS-xxx) are the next pyramid level. Detailed work instructions (i.e., WI-xxx) are the next level of the quality system. We generally recommend that the number of detailed work instructions is minimized. This is accomplished by limiting the scope of the work instructions to detailed operations that require step-by-step written instructions, such as manufacturing processes and inspection methods. The base of the document structure pyramid is quality system records. Each record is created by filling in blank forms (i.e., FRM-xxx) and logs (i.e., LST-xxx). The purpose of the document structure policy document, POL-002, is to give you a document where you can define other types of documents in your quality system, such as drawings (e.g., DWG-xxx).
What’s included with the Quality Manual (POL-001)?
The following is a list of documents included with the purchase of Medical Device Academy’s Quality Manual Template (POL-001):
To review a sample Medical Device Academy procedure click below:
Please note: This product will be delivered to the email address provided in the shopping cart transaction. After the transaction is verified, please check your email for the download. To view all available procedures click here.
About the Author
Matthew Walker – QMS, Risk Management, Usability Testing, Cybersecurity
Matthew came to us with a regulatory background that focused on OSHA and NFPA regulations when he was a Firefighter/EMT. Since we kidnapped him from his other career, he now works in Medical Device Quality Systems and Regulatory Pathways. He is a Junior in George Washington University’s BSHS- Clinical Research Management Program, and we are proud to say that he is also a member of both the Golden Keys and Phi Theta Kappa Honor Societies! Matthew participates as a member of our audit team and has a passion for risk management and human factors engineering. Always the mad scientist, Matthew pairs his professional life in regulatory affairs with hobbies in the culinary arts as he also holds a Butchers/Meat Cutters certificate from Vermont Technical College.
Our service procedure complies with ISO 13485 and 21 CFR 820.200, but now we are adding a training webinar to the bundle for SYS-013.
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Service Procedure (SYS-013) Webinar Bundle
SYS-013 - Servicing Procedure
SYS-013 Servicing Procedure - This servicing procedure pertains only to physical devices that your designed to be recalibrated, maintained, repaired, or refurbished. In general, disposable products and software products are excluded from the scope of this procedure. You will need to create your own detailed work instruction for service of your device(s). This procedure applies to medical devices distributed in the United States, Canada and the European Union.
Price: $299.00
The purpose of this procedure is to define your company’s service process. The service procedure pertains only to physical devices that are recalibrated, maintained, repaired, or refurbished. Disposable products and software products are generally excluded from the scope of this procedure. This procedure is the primary document meeting the applicable regulatory requirements for servicing as defined in the Quality System Manual (POL-001). It applies to medical devices distributed in the United States, Canada, and the European Union and has been written to conform with ISO 13485:2016.
When is the webinar about this service procedure?
This webinar was live on Monday, March 25, 2024, at 10:30 a.m. ET. It was recorded. You can purchase it on-demand and watch the training as often as you wish. There are 14 slides in the webinar and the duration of the training is ~30 minutes.
What you will receive:
A template for a service record and a service log are included with the procedure. FRM-008 is also included with this procedure because when a product is returned for service, it should be treated as non-conforming material and segregated from the released product. These documents are updated for ISO 13485:2016 and the new European Regulations. The following is a list of documents included:
SYS-013, Service Procedure
FRM-008, Nonconforming Material Report
FRM-013, Service Record
LST-013, Service Log
Native Slide Deck for Training Webinar
Recording of Training Webinar (March 25, 2024)
Please note: This product will be delivered to the email address provided in the shopping cart transaction. After the transaction is verified, please check your email for the download. To view all available procedures click here.
Robert Packard is a regulatory consultant with ~25 years of experience in the medical device, pharmaceutical, and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Robert was a senior manager at several medical device companies—including President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certification. From 2009-2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Robert’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications, and 510(k) submissions. His favorite part of his job is training others. He can be reached via phone 802.258.1881 or by email. You can also follow him on YouTube,LinkedIn or Twitter.
This webinar explains the FDA’s 510(k) requirements for shelf-life testing. This includes a discussion of the applicable consensus standard and how to create a testing plan.
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Shelf-Life Webinar ($79)
Shelf-Life Webinar
This webinar explains the FDA's 510(k) requirements for shelf-life testing. This includes a discussion of the applicable consensus standard and how to create a testing plan. You will learn how to avoid the most common mistakes that result in deficiencies that will delay 510(k) clearance. You will also learn how to add this information to the new FDA eSTAR template.
Price: $79.00
When is the Shelf-Life Webinar?
This webinar was live on Thursday, March 21, 2024. The webinar slide deck has 15 slides and the duration of the recording was 40 minutes. You can purchase it on-demand and watch the training as many times as you wish.
Why you should register for the Shelf-Life Webinar
You will learn how to avoid the most common mistakes that result in deficiencies that will delay 510(k) clearance. You will also learn how to add this information to the new FDA eSTAR template. Most important of all, you will learn why shelf-life testing is critical to review with the FDA in a pre-submission meeting.
What you will receive
a recording of the webinar you can replay anytime
the native slide deck for this webinar (15 slides)
FDA guidance for shelf-life testing of medical devices
FDA guidance for container closure integrity testing in lieu of sterility
If you would like to ask specific questions about preparing the Benchtop Performance Testing reports, please submit them via email or schedule a call using the calendar app on our Contact Us page. All content will be delivered via AWeber emails to confirmed subscribers. Please check your spam folder if you don’t receive the content automatically.
Q&A
Please email me at rob@fdaestar.com with questions about the Shelf-Life Testing Webinar. If you have company-specific questions, please request a private call to discuss your issues.
Additional Resources for 510k submissions
If you would like additional training on 510k submissions or you would like to access Medical Device Academy’s templates, you can purchase all of our templates and 510k webinars on our 510k course webpage.
About Your Instructor
Rob Packard is a regulatory consultant with ~25 years of experience in the medical device, pharmaceutical, and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Robert was a senior manager at several medical device companies—including President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certification. 2009-2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Rob’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications, and 510(k) submissions. His favorite part of his job is training others. He can be reached via phone 802.258.1881 or by email. You can also follow him on YouTube,LinkedIn or Twitter.
This webinar explains how to use the FDA Consensus Standards Database to determine which standards apply to your device.
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Consensus Standards Webinar ($79)
This webinar is included in our 510k Course series. You will be notified of the live webinar by email if you have already purchased the course. If you purchase the 510k Course series later, you can request a credit for your prior purchase.
Consensus Standards Webinar
This webinar explains how to use the FDA Consensus Standards Database to determine which standards are applicable to your device. The webinar also explains the difference between declaring conformity and general use of a standard. We explain ASCA certification in the video, and we teach you went to look-up standards in the 510(k) process.
Price: $79.00
Please note: This product will be delivered to the email address provided in the shopping cart transaction. After verifying the transaction, please check your email for the download (including your spam folder).
When is the Consensus Standards Webinar?
The live webinar is scheduled for March 14, 2024 @ 10:30 am ET. If you purchase the webinar before the live presentation, you will receive a link to participate in the live webinar via Zoom.
What you will receive
Access to download the recording of the webinar from our Dropbox folder
Native slide deck for this webinar
There will be 25-35 slides during the presentation. The presentation will be 45-50 minutes in duration.All deliveries of content will be sent via AWeber emails to confirmed subscribers.
Why you should register for the Consensus Standards Webinar?
This webinar explains how to use the FDA Consensus Standards Database to determine which standards apply to your device. The webinar also explains the difference between declaring conformity and the general use of a standard. We explain ASCA certification in the video and teach you how to look up standards in the 510k process.
About Your Instructor
Rob Packard is a regulatory consultant with ~25 years of experience in the medical device, pharmaceutical, and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Rob was a senior manager at several medical device companies—including the President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certifications. From 2009 to 2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Rob’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications, and 510(k) submissions. The most favorite part of his job is training others. He can be reached via phone at 802.281.4381 or by email.You can also follow him on YouTube,LinkedIn, or Twitter.
This Medical Device File procedure defines the requirements for medical device files to comply with ISO 13485:2016, Clause 4.2.3.
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Medical Device File Procedure
This procedure is based upon the requirement for CE Marking technical files and the GHTF Guidance for Summary Technical Documents (STEDs). The procedure meets the requirements for Medical Device Files (MDFs) in ISO 13485:2016, Clause 4.2.3. This procedure should be used for compliance with the new FDA QMSR, Health Canada’s SOR 98/282, and TGA regulations. The following is a list of what is included with this procedure/webinar bundle:
SYS-053 Medical Device File Procedure
FRM-xxx Essential Requirements Checklist (ERC)
FRM-040 Technical File Index/Device Master Record Index Template
Login information for the live webinar on Monday, March 4, 2024
Access to the record of the webinar if purchased after March 4, 2024
Native slide deck for the training webinar
Copy of the GHTF Guidance for Summary Technical Documents
SYS-053 Medical Device File Procedure
This procedure defines the format and content for a medical device file in accordance with ISO 13485:2016, Clause 4.2.3. The procedure and templates are bundled with a training webinar that is available on demand.
Price: $299.00
The Medical Device File procedure listed above is compliant with ISO 13485:2016, Clause 4.2.3. If you need the previous versions of our procedure and forms, please let us know.
Anyone who purchased an older version of this procedure from us is entitled to an updated version at no additional cost.
Other Training Resources
If your firm is preparing for compliance with ISO 13485:2016, you might also be interested in the following information provided on this website:
A webinar outlining how to create your own Quality Plan for compliance with the new FDA QMSR
A webinar teaching internal auditors and consultants how to perform a thorough audit of technical files against the requirements of the new EU regulations.
Please note: This product will be delivered to the email address provided in the shopping cart transaction. After the transaction is verified, please check your email for the download. To view all available procedures click here.
In this biocompatibility webinar, you will learn how to prepare your biocompatibility testing section for an FDA 510(k) submission.
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Biocompatibility Webinar ($79)
Biocompatibility Webinar
In this webinar you will learn how to create a summary technical document (STED) for biocompatibility testing to include in Section 15 of a 510k submission and for a CE Marking technical file.
Price: $79.00
Please note: This product will be delivered to the email address provided in the shopping cart transaction. After the transaction is verified, please check your email for the download (including your spam folder).
When is the Biocompatibility webinar?
This webinar will be live on Thursday, February 29, 2024 @ 10:30 am ET. The session will be recorded. You can purchase it on-demand and watch the training as often as you wish.
What you will receive
The most recent version of the STED biocompatibility testing template
Invitation to participate in the live webinar if you purchase this before February 29
Access to download the recording of the live webinar from our Dropbox folder
Native slide deck for this webinar
FDA Guidance on Biocompatibility
The presentation includes 34 slides, and the presentation was 44 minutes in duration.All deliveries of content will be sent via AWeber emails to confirmed subscribers.
Why you should register for the Biocompatibility Webinar
Notified Bodies prefer to receive a summary technical document (STED) describing the biocompatibility testing for a device rather than being forced to review each testing report in depth. In contrast, the US FDA requires that the full test reports be submitted for review. In addition, the FDA now has specific content questions that are asked in the FDA eSTAR template. These questions ask what conditions were used for testing, the rationale for the samples tested, and on what page information can be found within the testing reports. The FDA also provides a guidance document on the application of ISO 10933-1 that explains specific deviations from the ISO 10933-1 standard that the FDA requires.
Notified Bodies require that manufacturers follow the ISO 10993-1 Standard, and they will accept justifications for not conducting certain endpoint testing. The key to writing a STED is to include enough detail that the reviewer is confident that the required testing was performed, the testing methods were correctly executed and the results met the acceptance criteria. In addition, Notified Bodies need more information about the manufacturing processes, potential contaminants, and residues. The FDA focuses more on colorants and test methods.
In this webinar, you will learn exactly what information is required for both types of submissions and how much detail is required in order to avoid requests for additional information.
Q&A
Please submit questions to me by email at rob@13485cert.com regarding the Biocompatibility Webinar. If you have company-specific questions, please send me a request to set up a private call to discuss your specific issues.
Additional Resources for 510k submissions
If you would like additional training on 510k submissions or you would like to access Medical Device Academy’s templates, you can purchase all of our templates and 510k webinars on our 510k course webpage.
About Your Instructor
Rob Packard is a regulatory consultant with ~25 years of experience in the medical device, pharmaceutical, and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Rob was a senior manager at several medical device companies—including the President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certifications. From 2009 to 2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Rob’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications, and 510(k) submissions. The most favorite part of his job is training others. He can be reached via phone at 802.281.4381 or by email.You can also follow him on YouTube,LinkedIn, or Twitter.
To answer your questions about FDA 510k submissions, FDA compliance, or training, please contact us using the calendar links below.
For a free introductory call, please contact us
If you need help with your 510k submission, De Novo submission, other regulatory submissions, continuing education training, or QMS auditing for compliance, please contact us at Medical Device Academy. We also offer eCopy validation and uploading services if you do not have your own FDA Customer Communication Portal (CCP) account. Often, we can answer simple questions at no charge, or we may be able to recommend existing products that provide exactly what you need. If your needs are more complex, we can provide a consulting proposal.
Lindsey Walker, Director of Sales
Lindsey Walker studied at Castleton University, way back when it was just a little old Castleton State College in Castleton, Vermont, where she received her BS in Business Marketing. She also studied at North Country Community College, where she received her Certificate in Practical Nursing. Besides preparing proposals and sending out invoices, Lindsey was recently promoted to Director of Sales. In this new position, she is responsible for managing the sales team, coordinating introductory calls with our clients, creating proposals, and managing our new billing clerk. Lindsey loves cars, but when she is not behind the wheel of one, you can find her on a pottery wheel.
Typically, medical device consulting clients schedule calls using our calendly app. Rob typically starts his day with calls to European clients and Western Asia around 6 am and calls with the West Coast often extend past 6 pm. If you cannot find time on Rob’s calendar, please schedule a call with Lindsey. She will get you the answers you need and provide you with quote or proposal for consulting work. Our Mobile/Whatsapp numbers are provided on the scheduling calls page. If you are looking for testimonials, please visit our testimonials page.
Rob Packard, President
Rob Packard is a regulatory consultant with ~25 years of experience in the medical device, pharmaceutical, and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Rob was a senior manager at several medical device companies—including the President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certifications. From 2009 to 2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Rob’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications, and 510(k) submissions. The most favorite part of his job is training others. He can be reached via phone at +1.802.281.4381 or by email. You can also follow him on YouTube, LinkedIn, or Twitter.
This webinar will teach you about the Dual 510(k) and CLIA waiver submission options using the FDA eSTAR template.
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Dual 510(k) and CLIA Waiver Webinar ($79)
Dual 510(k) and CLIA Waiver Webinar
In this webinar, you will learn the requirements for a CLIA waiver and the dual submission of a 510(k) and CLIA waiver. The webinar will also demonstrate how to include this information in your FDA eSTAR submission.
Price: $79.00
When is the Dual 510(k) and CLIA Waiver Webinar?
This webinar will be live on Thursday, February 15, 2024 @ 10:30 am ET. The session will also be recorded. You can purchase it on-demand and watch the training as often as you wish.
Why you should register for the Dual 510(k) and CLIA Waiver Webinar
You will learn the requirements for a CLIA waiver and the dual submission of a 510(k) and CLIA waiver. The webinar will also demonstrate how to include this information in your FDA eSTAR submission. Slides 2-18 of this webinar are specific to the CLIA waiver requirements that are applicable to CLIA waivers even if you do not submit a dual 510k and CLIA waiver. Slides 19-26 are specific to the dual 510k and CLIA waiver submission requirements. The presentation includes training on study design, human factors testing, labeling, and flex studies.
What you will receive
an invitation to participate in the live webinar (if you purchase prior to February 15)
a recording of the webinar you can replay anytime
the native slide deck for this webinar (28 slides)
training on how to apply the CLIA waiver guidance from the FDA
training on how to apply the Dual 510(k) and CLIA waiver guidance from the FDA
copies of three different FDA guidance documents related to CLIA waivers
If you would like to ask specific questions about preparing the dual submission of a 510(k) and CLIA waiver, please submit them via email or schedule a call using the calendar app on our contact us page.All content deliveries will be sent via AWeber emails to confirmed subscribers. If you don’t receive the content automatically, please check your spam folder.
Q&A
Please submit questions to me by email at rob@13485cert.com regarding the 510(k) and CLIA waiver Webinar. If you have company-specific questions, please send me a request to set up a private call to discuss your specific issues.
Additional Resources for 510k submissions
If you would like additional training on 510k submissions or you would like to access Medical Device Academy’s templates, you can purchase all of our templates and 510k webinars on our 510k course webpage.
About Your Instructor
Rob Packard is a regulatory consultant with ~25 years of experience in the medical device, pharmaceutical, and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Rob was a senior manager at several medical device companies—including the President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certifications. From 2009 to 2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Rob’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications, and 510(k) submissions. The most favorite part of his job is training others. He can be reached via phone at +1.802.281.4381 or by email.You can also follow him on YouTube,LinkedIn, or Twitter.
Learn how to create a UDI procedure for compliance with the FDA and EU regulatory requirements for UDI compliance.
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What’s included in our UDI Procedure?
The UDI procedure complies with ISO 13485:2016 as well as the European and US regulations. The procedure includes the following list of documents:
SYS-039 A D5 UDI Requirements Procedure
FRM-016 A D1 FDA UDI Checklist
FRM-017 A D2 EU UDI Checklist
We are including a training webinar explaining the FDA’s UDI System and the native presentation slide deck, and we will provide an exam (i.e., a 10-question quiz) to verify training effectiveness. If you submit the completed exam to us by email in the native MS Word format, we will correct the exam and email you a training certificate with your corrected exam. The FDA website also provides information about the UDI system. We also provide email notifications of free updates to the procedure and forms when we update the procedure to comply with new and revised regulations.
SYS-039 - UDI Requirements Procedure, Webinar and Exam Bundle
SYS-039, UDI Requirements Procedure Bundle; This training includes our procedure for UDI Requirements and the FDA template for the GUDID data elements. You will also receive a link to download our slide deck and webinar recording on UDI labeling. We also provide a 10 question quiz on the FDA's UDI requirements and a training certificate when you complete the quiz and submit it to Medical Device Academy for grading.
Price: $299.00
What countries does this UDI procedure apply to?
A Unique Device Identifier or UDI is required for all in vitro diagnostics (IVD) and devices in the USA and Europe to identify the manufacturer, the device or IVD itself, and production-related details such as the date of manufacture and the lot number. To comply with these UDI requirements, you will need a UDI procedure compliant with the US regulations (i.e., 21 CFR 830 and parts of 21 CFR 801). To comply with European regulations, you will need a UDI procedure compliant with Article 24 and Annex VI of the IVDR and Article 27 and Annex VI of the MDR. The video below provides an overview of Medical Device Academy’s UDI procedure.
What is a UDI?
UDI stands for ‘Unique Device Identifier.’ This two-part identification code is used as part of the FDA’s Unique Device Identifier System. The FDA issued its final rule on Unique Device Identifier Systems on September 24, 2013, effective December 23, 2013. The full 44-page document can be viewed on the Federal Register Website.
The idea or concept of having an identifier unique to each medical device is not a flashy new concept and has been used in other industries for many years. A UDI could be comparable to a VIN and license plates for vehicles or even social security numbers and driver’s license numbers in people. The idea is that there is a trackable piece of information that identifies individual types of medical devices.
The Two Parts of a UDI
A UDI includes two parts. One is the ‘Device Identifier’ or DI, and the other is the ‘Production Identifier’ or PI. The DI portion is the ‘Device Identifier.’ This portion of the UDI is mandatory and serves to identify the labeler and the specific model of the labeled device. Once the DI has been assigned, it is permanent and cannot be changed. Every variable of the device will require its own DI. For example, if multiple sizing options were produced for a device, then each size available would require a DI. Other variances, such as color and cosmetic or ergonomic design differences, also require separate DI numbers.
The ‘Production Identifier’ or PI and unlike the device identifier the PI identifies one of several pieces of information. I feel the best way to explain the PI’s information is to quote the FDA directly.
“a production identifier (PI), a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of a device:
the lot or batch number within which a device was manufactured;
the serial number of a specific device;
the expiration date of a specific device;
the date a specific device was manufactured;
the distinct identification code required by §1271.290(c) for a human cell, tissue, or cellular and tissue-based product (HCT/P) regulated as a device.” (FDA, UDI Basics 2015).
If a company were to produce multiple batches or lots of a device, the DI would remain the same, but the PI would differ for each batch produced.
UDI Formats
Your UDI must be provided in two separate formats. One is a plain text version that is simply an alphanumeric code that correlates with the information that it is trying to convey. This is a DI/PI code that must be labeled on the packaging of your medical device or, in some cases, on the device itself.
A second format is a form that is AIDC compatible. AIDC stands for ‘Automatic Identification and Data Capture’. AIDC collects your information without having to enter all of your data manually. Generally, this is some type of barcode or QR code.
You can see examples of AIDC technology in our daily lives. Some of the most common examples are barcodes, as mentioned above, and magnetic strips and chips as we see in our credit and debit cards. RFID, optical scanners, and other biometrics are also included as some of the less common AIDC methods.
For more information on AIDC technology in general, you can follow the 3rd party website.
Your UDI should be located on your device label. This is a general rule, but the FDA has multiple exemptions and alternatives based on the device use and classification. The UDI’s are required to be directly marked on the devices themselves should they be intended to be used more than once and be reprocessed before each use.
If you are writing a UDI procedure for your company, double-check that your device does not fall under any of the FDA’s exceptions.
An example of one of the exceptions that may apply to your device is, “If your device is Class I, you may use a Universal Product Code (UPC) to serve as the UDI on the device label and package. In addition, the UDI on your class I devices is not required to include a PI.” (FDA, Small Entity Compliance Guide, 2014).
Packaging Levels for UDI
Each ‘package level’ also requires a new DI. For example, if your medical device were an insulin syringe that you sold in packages of 10 and bulk in packages of 100, each would need an individual ‘Device Identifier’. This does not mean that each package of 10 or 100 needs its own DI. These are not a lot or batch numbers. These numbers are for the user’s information, so shipping materials such as pallets and shrink wrap do not require DI/PI labeling. However, different models or any substantial updates to the medical device will need its DI.
As long as your syringe is only sold as an individual syringe, the UDI and labeling are compliant. As soon as an additional packaging level is introduced, an additional UDI is required. Using the same syringe example, if the syringes are also sold in packages that contain five of your already labeled medical devices, that package needs its UDI number. Another UDI would be required if the syringes were sold in packages of ten, twenty-five, or fifty. Every level of packaging that the device is sold in requires a UDI.
What is not considered an additional packaging level? Measures to protect your products during shipping are not considered additional packaging levels. This includes palletizing and wrapping your products to protect them from damage during shipping. Pallets, shipping containers, and trailers do not require a UDI.
Updated Products and UDI’s
UDI’s are specific to individual models of products and devices. As each packaging level or product variance, such as size offered, requires a UDI, so does each device change and upgrade. Say you launched your device 2 years ago and, based on consumer feedback, decided to make some changes to your device. Your device’s new version is no longer the same as the one that had the previous UDI issued to it.
You would now need a UDI for the essentially ‘new product.’ You must also address the same compliance requirements for packaging levels and variances as you did with the original product. As you update your product, be aware that you may need to update your UDI.
UDI date format requirements
The date format on device labels should be in the ‘International Standard’, which consists of Year-Month-Day as opposed to what would normally be seen in the United States, which is Month-Day-Year. For example, the date for April 18, 2018, would need to be written 2018-04-18.
This format would need to be used on your labeling for things such as your product’s or device’s manufacture and expiration date.
For UDI labels, the compliance date for implementing the International Date Standard will be the same as the compliance dates for UDI/AIDC.
Compliance Dates for Class I and Unclassified Devices.
Below is the FDA’s UDI Compliance Dates Table.
To extend the compliance dates for lower-risk medical devices, the FDA plans to issue a guidance document to provide an enforcement discretion policy for labeling, GUDID data submission, standard date formatting, and direct mark requirements for class I and unclassified devices, as indicated in Figure 1 below. This enforcement discretion policy would not apply to class I or unclassified implantable, life-supporting, or life-sustaining devices1 because labelers of these devices must already comply with UDI requirements.
Type of Device
Label (21 CFR 801.20), GUDID Submission (21 CFR Part 830, subpart E), and Standard Date Format (21 CFR 801.18) Requirements
Direct Mark (21 CFR 801.45) Requirements
Class 1 devices2
September 24, 2020
September 24, 2022
Unclassified devices
September 24, 2020
September 24, 2022
Figure 1
1 For implantable, life-supporting or life-sustaining devices of all classes, the compliance date for all UDI requirements and the standard date format requirement (21 CFR 801.18) was September 24, 2015. 2 Class I CGMP-exempt devices are excepted from UDI requirements. 21 CFR 801.30(a)(2)
Compliance Dates Established by FDA in Conjunction with UDI Final Rule
Compliance Date
Requirement
1 year after publication of the final rule (September 24, 2014)
The labels and packages of class III medical devices and devices licensed under the Public Health Service Act (PHS Act) must bear a UDI. § 801.20. Dates on the labels of these devices must be formatted as required by § 801.18. Data for these devices must be submitted to the GUDID database. § 830.300. A 1-year extension of this compliance date may be requested under § 801.55; such a request must be submitted no later than June 23, 2014. Class III stand-alone software must provide its UDI as required by § 801.50(b).
2 years after publication of the final rule (September 24, 2015)
A device that is a life-supporting or life-sustaining device that is required to be labeled with a UDI must a bear UDI as a permanent marking on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use. § 801.45. Stand-alone software that is a life-supporting or life-sustaining device must provide its UDI as required by § 801.50(b).
Data for implantable, life-supporting, and life-sustaining devices that are required to be labeled with a UDI must be submitted to the GUDID database. § 830.300.
3 years after publication of the final rule (September 24, 2016)
Class III devices required to be labeled with a UDI must bear a UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use. § 801.45.
The labels and packages of class II medical devices must bear a UDI. § 801.20. Dates on the labels of these devices must be formatted as required by § 801.18. Class II stand-alone software must provide its UDI as required by § 801.50(b).
Data for class II devices that are required to be labeled with a UDI must be submitted to the GUDID database. § 830.300.
5 years after publication of the final rule (September 24, 2018)
A class II device that is required to be labeled with a UDI must bear a UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use. § 801.45.
The labels and packages of class I medical devices and devices that have not been classified into class I, class II, or class III must bear a UDI. § 801.20. Dates on the labels of all devices, including devices that have been excepted from UDI labeling requirements, must be formatted as required by § 801.18.
Data for class I devices and devices that have not been classified into class I, class II, or class III that are required to be labeled with a UDI must be submitted to the GUDID database. § 830.300. Class I stand-alone software must provide its UDI as required by § 801.50(b).
7 years after publication of the final rule (September 24, 2020)
Class I devices, and devices that have not been classified into class I, class II, or class III that are required to be labeled with a UDI, must a bear UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use. § 801.45.
Compliance dates for all other provisions of the final rule. Except for the provisions listed above, FDA requires full compliance with the final rule as of the effective date that applies to the provision.
UDI Quality System Requirements
To comply with both Part 803.22 Medical Device Reporting and 820.198 Quality System Regulation, the documentation of UDI numbers included on device labeling is either required specifically or applicable to fulfill specific documentation and reporting requirements.
CFR 21 Chapter I Sub Chapter H Medical Devices Part 803.33 Medical Device Reporting
“(a) You must submit to us an annual report on Form FDA 3419. You must submit an annual report by January 1, of each year. You may obtain this form from the following sources:
(iv) Product model, catalog, serial, and lot number and unique device identifier (UDI) that appears on the device label or on the device package.”
For handling complaints as part of your quality system, inclusion of the UDI in your record of investigation is a specifically listed portion of device identifications and control numbers needed for reporting and record keeping.
Quality System Regulation Sub Part M Records 820.198
“(e) When an investigation is made under this section, a record of the investigation shall be maintained by the formally designated unit identified in paragraph (a) of this section. The record of investigation shall include:
(1) The name of the device;
(2) The date the complaint was received;
(3) Any unique device identifier (UDI) or universal product code (UPC), and any other device identification(s) and control number(s) used;”
All UDIs are required to be issued under a system operated by an FDA-accredited “Issuing Agency”. At the time of writing this, the FDA currently only has three FDA-accredited IA’s. They are GS1, HIBCC, and the ICCBBA. The UDI rule provides a process through which an agency would seek FDA accreditation. specifies the information that the applicant must provide to FDA and the criteria FDA will apply in evaluating applications.
To seek accreditation by the FDA as a UDI issuing agency, your UDI procedure must define the process outlined in the 21 CFR 830 Subpart C. This specifies the information that must be provided to the FDA as well as the FDA evaluation criteria. The FDA also asks that agencies seeking an initial accreditation contact the FDA directly at gudidsupport@fda.hhs.gov.
UDI Procedure for Labelers
Labelers are ultimately the ones that are responsible for complying with the FDA’s UDI labeling requirements. Are you a labeler? In most cases, but not always, the brand owner is typically the labeler.
The FDA defines a labeler as “(1) Any person who causes a label to be applied to a device with the intent that the device will be commercially distributed without any subsequent replacement or modification of the label; and
(2) Any person who causes the label of a device to be replaced or modified with the intent that the device will be commercially distributed without any subsequent replacement or modification of the label, except that the addition of the name of, and contact information for, a person who distributes the device, without making any other changes to the label, is not a modification for the purposes of determining whether a person is a labeler” (FDA, Webinar UDI 101)
Distributors add contact information only
A distributor may add their contact information to a label. As long as they are not altering the label in any other way. Alterations made to the label beyond this may constitute a change in who exactly is the labeler of the product.
Do Foreign device manufacturers need a UDI procedure?
UDI labeling rules apply to all medical devices sold within the United States and Europe. Therefore, even if your company is located outside the US or Europe, you will need a UDI procedure, and you must comply with the UDI regulations to distribute products in these two markets.
GUDID Requirements for your UDI Procedure
GUDID stands for Global Unique Device Identification Database. This database is a reference catalogue that is open for viewing by the public for every medical device with an ‘identifier’. This database can be accessed through AccessGUDID. Unlike submission, which requires an account, AccessGUDID may be accessed by anyone.
Under the UDI Rule, the FDA requires labelers who have medical devices that are labeled with a UDI to submit their device to the GUDID. If you are wondering if your device has such a labeler, we referenced above that the FDA considered the labeler to be “the person who causes a label to be applied to a device, or who causes the label to be modified, with the intent that the device will be introduced into interstate commerce without any subsequent replacement or modification of the label; in most instances, the labeler would be the device manufacturer, but the labeler may be a specification developer, a single-use device reprocessor, a convenience kit assembler, a repackager, or a relabeler.”
The GUDID is created with data about devices according to the compliance timeline table shared above and is published in conjunction with the UDI rule. The GUDID only contains the device identifier, which is the primary key to obtaining device information in the GUDID database. Production Identifiers are not submitted or stored in the GUDID.
Lindsey Walker studied at Castleton University, way back when it was just a little old Castleton State College in Castleton, Vermont, where she received her BS in Business Marketing. She also studied at North Country Community College, where she received her Certificate in Practical Nursing. Besides preparing proposals and sending out invoices, Lindsey was recently promoted to Director of Sales. In this new position, she is responsible for managing the sales team, coordinating introductory calls with our clients, creating proposals, and managing our new billing clerk. Lindsey loves cars, but when she is not behind the wheel of one, you can find her on a pottery wheel.
