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How To Address Device And Regulatory Change From A Biocompatibility Perspective

Many devices are a modified version of the “clean slate” device that was placed on the market decades ago and devices frequently change hands from one company to another and are submitted to new markets. Currently, biocompatibility is one of the most rapidly changing regulatory sections in the medical device industry. Mainly contributed to a universal drive to reduce animal testing and the new MDRs.
This webinar addresses:

  • What constitutes a change to a medical device?
  • Do I need to repeat all of my biocompatibility when a change is made?
  • How to address new standards
  • How can I use supplier information to support biocompatibility?
  • Is the biocompatibility testing from 1994, or 2000, or 2010 still applicable to my device?

 

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...