This ebook from Nelson Laboratories, LLC, provides a digest of pressing challenges and solutions for medical device design, development, and testing with regard to biocompatibility and toxicology planning, testing, and compliance. It is intended to serve as a guide for professionals and teams involved in QA/QC, quality engineering, R&D, regulatory affairs, manufacturing, and consulting in related areas.
In this ebook, you’ll also learn about:
- Updates to ISO 10993 standard
- Understand the EU MDR updates and how it will affect you
- Extractable and Leachable testing for medical devices
- Addressing cytotoxicity failures