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PUBLISHED ARTICLE

FDA Guidance for ISO 10993-1: What to Expect

Published In: MD&DI Online

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.

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Audrey Turley

Audrey Turley

BS, RM (NRCM), CBA (ASQ)
Biocompatibility Expert

Audrey Turley has 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 Labs, which include cytotoxicity (MEM and agar overlay), hemolysis (PTT, PT, complement activation, blood circulation, ASTM, and NIH methods), and...