Nelson Labs hosted a half-day Seminar at MD&M East on June 12, 2019. The PDF of the presentation from this seminar is now available! Contact [email protected] for more information.
Presenter: Thor Rollins, Director, Toxicology & E&L Consulting, Nelson Labs, LLC
Part 1- ISO 10993-1 Biocompatibility (Applying the New ISO 10993 Standards)
- An 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 the FDA?
Part 2- ISO 10993-18 What is E&L and How to Evaluate Changes to Medical Devices
- What is the current regulatory status of extractable & leachable testing?
- How can we make sure the regulatory bodies will accept our E&L studies?
- If a material is changed, how is safety impacted?
- If the change is small, is do you need to retest?
- What if I change a manufacturing process, do you need to retest?
Part 3- MDRs Riding out the Storm
- What changes do the MDR bring and how much time do I have to comply?
- Will Brexit impact my European submission?
- What will my Notified Body be looking for with regard to the MDR?
- Case study regarding different approaches