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Whitepaper

WHITEPAPER

Biocompatibility Fundamentals for Medical Devices eBook

This eBook contains guidelines for planning, risk mitigation, testing, and compliance for the design and manufacture of medical devices. It provides a digest of pressing challenges and solutions for medical-device design, development, and testing with regard to biocompatibility and toxicology planning, testing, and compliance. It is intended to serve as a guide for professionals and teams involved in quality assurance, quality control, quality engineering, R&D, regulatory affairs, manufacturing, and consulting in related areas.

Table of Contents:

  • The New and Improved ISO 10993-12:2021: What Is Really Changing
  • Understanding the EU Medical Device Regulation for Device Companies
  • FDA Draft Guidance for Biocompatibility of Certain Devices in Contact with Intact Skin: the Naughty and Nice List
  • 3D Medical Devices and Biocompatibility
  • Medical Device Extractables and Leachables Testing in 2020
  • Choosing Colorants for Medical Devices
  • How to Address Failed Cytotoxicity Testing on Medical Devices

Read about the authors below.

Audrey Turley

Audrey Turley

BS, RM (NRCM), CBA (ASQ)
Senior 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 Laboratories, which include cytotoxicity (MEM and agar overlay), hemolysis (PTT, PT, complement activation, blood circulation, ASTM, and NIH methods),...

Helin Räägel

Helin Räägel

PhD
Senior Biocompatibility Expert

Dr. Räägel is a globally recognized expert in medical device biocompatibility. She has extensive expertise in writing biological evaluations and assessments for regulatory submissions. These documents focus on using a risk-based approach in defining the path to evaluating medical devices, with US FDA and EU regulatory bodies as the primary audience. She works closely with...

Matthew Jorgensen

Matthew Jorgensen

PhD, DABT
Chemistry and Materials Scientist

Dr. Jorgensen is an expert in chemistry and materials science. He has over a decade of experience designing, synthesizing, and analyzing complex materials. His analytical chemistry background includes research in organic chemistry synthesizing and analyzing a naturally occurring anti-cancer drug, computational treatment of photothermal spectroscopy, and professionally in a commercial lab. Most of his materials...

Sarah Campbell

Sarah Campbell

PhD, DABT
Principal Toxicologist

Dr. Campbell is a Board Certified Diplomate of the American Board of Toxicology. She has over 20 years of experience working in toxicological research, 20 years of applied analytical chemistry experience, 14 years of experience in pharmaceutical research (including both clinical and nonclinical), and 12 years of experience as a bench chemist. Her particular areas...

Thor Rollins

Thor Rollins

BS, RM (NRCM)
Toxicology and E&L Expert

Thor Rollins is a certified microbiologist and specializes in the selection and conduct of in vitro and in vivo biocompatibility tests. He actively speaks on biocompatibility related topics through Nelson Labs’ external seminars, webinars, and tradeshows. He presented on biocompatibility at the American College of Toxicology annual meeting in 2013 and has published many articles...

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