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.
When is this Medical Device Reporting Webinar?
On Thursday, June 9 we will be hosting a live webinar on Medical Device Reporting at 2 different times:
- 7am EDT…For our European clients and morning people 🙂
- 1pm EDT…for our US clients and night owls 😉
Anyone purchasing this webinar / procedure bundle will receive a recording for both webinar time slots.
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 (2 recordings this time). You will receive the procedure for Medical Device Reporting (SYS-029) which has been updated to include requirements for ISO 13485:2016 and eMDR Submissions to the FDA. There are no forms associated with this procedure, because you must submit eMDRs using and electronic submissions gateway. However, you will receive a copy of our updated 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.
Medical Device Reporting Webinar Bundle
You can register for this live training webinar / procedure bundle for a cost of $299. You will receive:
- login information for the live webinar including Q&A @ 7:00am EDT & 1:00pm EDT, June 9
- our New FDA 483 Whitepaper including Data Analysis of FY 2015 inspection observations
- a native slide deck for the webinar (25-35 slides)
- an exam and training certificate (10 question quiz and PDF certificate with corrected exam)
- a link to download both recordings of the live webinar (~1 hour long each)
This live webinar includes 45-50 minutes of presentation slides and 10-15 minutes of answering questions submitted through the live chat window. Both recordings will cover the exact same slides, but there will be different questions asked during each webinar recording The presentation 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.
If you have any generic questions about Medical Device Reporting, or the eMDR requirement in 21 CFR 803, please email me at email@example.com. I will use your questions as material for webinars and future blogs. During live webinars you are only be able to submit questions via the chat box. If you have company-specific questions, please send me a request to set-up a private call to discuss your specific issues.
Medical Device Reporting Webinar Bundle available for $299.00:
SYS-029, Medical Device Reporting Procedure; Get the training you need on eMDRs to avoid an FDA 483. Access 2 live sessions (same content), native slide deck, updated procedure and exam with training certificate.
VIEW OUR PROCEDURES – CLICK HERE OR IMAGE BELOW:
About Your Instructor
Rob Packard is a regulatory consultant with ~25 years 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 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. 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 802.281.4381 or email. You can also follow him on Google+, LinkedIn or Twitter.