The Medical Device Reporting (MDR) procedure and webinar bundle will teach you to determine if a complaint requires reporting to the US FDA.
When is the Medical Device Reporting (MDR) Webinar?
Since medical device reporting is one of the most common FDA 483 inspection observations, we created this procedure and webinar bundle to help your complaint handling unit comply with 21 CFR 803. This webinar was hosted as a live webinar on June 9, 2016, but we are updating it, and it will be hosted live on December 14, 2023. Anyone purchasing this webinar/procedure bundle will receive a link for downloading the recordings and an invitation to the live webinar if they register before December 14, 2023.
Medical Device Reporting (MDR) Procedure and Webinar Bundle available for $299.00:
The following is a list of documents included in the bundle:
- SYS-001 v0.2, Medical Device Reporting Procedure
- LST-011 v0.1, Complaint Register
- eSubmission User Manual (11/6/2020)
- eSubmitter Quick Guide (3/30/2023)
- FDA eSubmitter FAQs (3/30/2023)
- Mac Install Instructions (12/3/2023)
- Most Common Issues (March 2023)
- Zipped eSubmitter Software Download (64-bit)
- FDA Guidance on Medical Device Reporting (November 8, 2016)
- a native slide deck for the webinar
- a link to download the recording of the webinar
- a quiz and training certificate
The procedure does not include instructions for creating an electronic submissions gateway (ESG). The ESG work instructions are sold separately (i.e., WI-003), and the ESG work instructions will be updated during 2024 as the FDA releases the ESG NextGen. The webinar explains how to make medical device reporting decisions and how to establish an electronic submissions gateway (ESG) in order to submit MDRs to the FDA. All deliveries of content will be sent via Aweber emails to confirmed subscribers.
Medical Device Reporting is a Huge Problem
In FY 2015, there were 294 FDA Form 483 inspection observations specific to compliance with 21 CFR 803 (i.e., Medical Device Reporting). Failure to make MDR determinations correctly and in a timely manner also results in a very large percentage of the Warning Letters issued by the FDA to US and Foreign manufacturers. Experienced medical device manufacturers know that they need personnel to be trained on how to make reporting decisions correctly. In fact, foreign firms invest the most in this type of training because if a foreign firm receives two Warning Letters they will have products placed on automatic import detention for the next 18-24 months while they wait for the FDA to return for a Level 3 inspection to close the Warning Letter.
Medical Device Reporting Webinar Bundle
Typically, webinars are sold on our website for $129, and procedures are sold for $299. This bundle will be sold for $299. As always, you will receive a copy of the native slide deck and a link for downloading the recording. You will receive the procedure for Medical Device Reporting (SYS-029), updated to include requirements for ISO 13485:2016 and eMDR Submissions to the FDA. No forms are associated with this procedure because you must submit eMDRs using an electronic submissions gateway. However, you will receive a copy of our complaint log (LST-011) that will help you monitor the reporting decisions to ensure that the complaint handling process and reporting decisions are processed consistently and efficiently. Reporting on this data is a new requirement for management reviews in ISO 13485:2016.
Q&A
If you have any general questions about Medical Device Reporting or the eMDR requirement in 21 CFR 803, please email me at rob@fdaestar.com. I will use your questions as material for webinars and future blogs. During live webinars, you are only able to submit questions via the chatbox. If you have company-specific questions, please send me a request to set up a private call to discuss your specific issues.
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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 +1.802.258.1881 or by email. You can also follow him on YouTube, LinkedIn, or Twitter.