The IVD 510k webinar gives you the basics of preparing a 510k submission for the FDA and explains key differences between an IVD and a non-IVD 510k.
Why you should register for the IVD 510k Webinar
Eighty percent of an IVD 510k submission is the same as a 510k submission for non-IVD medical devices. Many regulatory experts with only non-IVD experience are afraid to tackle their first IVD 510k submission, but the sections and documents that are unique to IVD products are easy to learn. This webinar explains how to find IVD predicates and how to write an IVD device description. Most important of all, you learn how to plan for the differences in performance testing requirements.
What you will receive for $29
- access to the live webinar (new Zoom platform)
- a recording of the webinar you can replay anytime (mp4 format)
- the most recent version of the device description template for IVD products (Word doc)
- the native slide deck for this webinar (PPT format)
There will be 25-35 slides during the presentation. The presentation will be 45-50 minutes in duration, and you will have the opportunity to ask questions during the live webinar. Content will be sent via AWeber emails to confirmed subscribers.
IVD 510k Webinar ($29)
In this webinar you will learn the basics of preparing a 510k submission specifically for an in vitro diagnostic (IVD) product.
When is the IVD 510k Webinar?
On Friday, March 17 we will be hosting the IVD 510k Webinar live at 10:00 am EDT.
Q&A
Please submit questions to me by email at rob@13485cert.com regarding the IVD 510k 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 Google+, LinkedIn, or Twitter.