Several noteworthy changes are anticipated in a new FDA guidance document on biological evaluation and biocompatibility testing of medical devices due out sometime this year.
FDA Guidance for ISO 10993-1: What to Expect
Published In: MD&DI Online
January 20, 2016
RM (NRCM), CBA (ASQ)
Director of Expert Advisory Services & Biocompatibility Expert
Audrey Turley has over 25 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 Labs, which include cytotoxicity (MEM and agar overlay), hemolysis (PTT, PT, complement activation, blood circulation, ASTM, and NIH methods),...