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?
Audrey Turley, B.S., RM (NRCM), CBA (ASQ)
Senior Biocompatibility Expert
Nelson Laboratories, LLC
Audrey Turley has over 20 years of experience working in research, laboratory, and test design functions in the medical device industry. She is a biocompatibility expert having performed all the in vitro tests offered at Nelson Laboratories, which include cytotoxicity (MEM and agar overlay), hemolysis (PTT, PT, complement activation, blood circulation, ASTM and NIH methods), and genotoxicity (Ames and chromosome aberration). Audrey is part of a team at Nelson Laboratories that recently completed round robin testing for an in vitro irritation assay in an effort to gain acceptance by regulatory bodies in the United States and Europe. Audrey works with medical device manufacturers around the globe to develop appropriate biocompatibility strategies to ensure compliance to standards and regulatory expectations.
Audrey is an active committee member of many working groups with the Association for the Advancement of Medical Instrumentation (AAMI):
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