Whitepaper

WHITEPAPER

Biocompatibility Fundamentals for Medical Devices eBook

April 7, 2022 | By: Audrey P. Turley, Helin Räägel, Matthew Jorgensen, Sarah Campbell and Thor Rollins

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FDA Draft Guidance for Biocompatibility of Certain Devices in Contact with Intact Skin: the Naughty and Nice List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

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),...

Helin Räägel, PhD

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...

Sarah Campbell, PhD

DABT
Toxicology Expert

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

RM (NRCM)
Biocompatibility 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...

Matthew R Jorgensen, Ph.D.

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. To characterize materials, Dr. Jorgensen has extensively used a wide variety of techniques including GC/MS, LC/MS, FTIR, UV/VIS, SEM, NMR, and several types of advanced spectroscopic techniques. His Ph.D. in Physical Chemistry from the University of Utah was based on the fabrication and analysis of titanium dioxide and silicon dioxide photonic crystals templated from the three-dimensional structure found in the exoskeleton of exotic weevils. During his time at the University of Utah, he received the Henry Eyring Research Fellowship, the DOW Chemical First Year Scholarship, and additional grants to travel and present his research at national and international conferences. His research has resulted in over 30 peer-reviewed publications.