A new updated ISO 10993-1 standard came out in Aug of 2018 that drastically changed how we access medical devices for biocompatibility. We also are dealing with the impact of the Medical Device Regulations in Europe. The timing of these two documents has greatly disrupted the medical device industry. In this webinar we will discuss the changes and efficient approaches to navigate through the troubles.
By attending this webinar you will learn:
- Overview of the new ISO 10993-1
- Performing a Biological Evaluation Plan
- Overview of the “Big Three” including new in vitro alternatives
- What is needed in a Biological Evaluation Report for FDA?
Presenter: Thor Rollins, Director of Toxicology and E&L Consulting
