Medtech Snapshot: Trisha Aure - Differences Between ISO 13485 and 21 CFR 820 (Highlights)

In this 2-part series of Medtech Snapshot we're joined by Square-1 Engineering Director of Delivery & Operations Trisha Aure as she walks us through the highlights of our article 'FDA Announcement: 21 CFR 820 and ISO 13485 Guidance'

Hear the areas where 21 CFR 820 differs most from ISO 13485 and what this means for medical device OEMs. ​Part-2 of this series will cover the process to transition and key considerations when doing so.

Transcript:

Read More