Presenter: Audrey Turley, B.S. RM (NRCM)

Starting with a biocompatible material is important for medical device manufacturers. However, regulation is pushing the manufacturer to ask for more information and more support from their suppliers. Biocompatibility on materials is critical to stay competitive and provide your clients with the needed information. Topics covered include:

• An overview of ISO 10993-1
• MDR regulation regarding carcinogens, mutagens, and reproductive toxins (CMRs) for raw materials
• Where is the line in responsibility for material supplier and device manufacturer?
• What information and testing on raw material is useful for the biocompatibility of a final device?