Medical devices must be proven safe and effective under all conditions of use, making a well-designed, device-specific test plan essential. These plans consider factors such as intended use, transport, environment, and end users to ensure reliable performance. In this Q&A, experts from Nelson Labs and Regulatory Compliance Associates discuss key considerations for developing test plans that meet global regulatory expectations. Read the full Q&A article published in Medical Product Outsourcing (MPO) to learn more.
Designing a Test Plan that Works Globally—A Medtech Makers Q&A
Published In: Medical Product Outsourcing (MPO)
April 23, 2026
Audrey Turley
RM (NRCM), CBA (ASQ)
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),...
Jordan Elder
RAC
Regulatory Affairs Expert
Jordan has 15 years of experience navigating regulatory pathways and identifying optimal regulatory strategies for pharmaceutical and medical device companies. As Director of Regulatory Affairs for Regulatory Compliance Associates (RCA) he is responsible for providing clients with general direction, tactical objectives, and functional plans for their regulatory needs. Jordan is a meticulous regulatory professional with...
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...
