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 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 10:00am EDT.
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.