What medical device manufacturers need to know about the recent changes to the ISO bioburden standard.
Five Aspects of the ISO 11737-1:2018 Updates You Need to Know
Published In: Medical Device Outsourcing
July 23, 2018
BS, RM (NRCM), CQA (ASQ)
Senior Manager, Expert Advisory Services
Wendy Mach has over 27 years of medical device manufacturing and laboratory experience. She worked in the medical manufacturing environment in Minnesota for seven years, performing ethylene oxide (EO) and gamma radiation sterilization validations. While at the manufacturing site, she also insourced the microbiology tests for sterility assurance and related equipment validation. Wendy also spent...
BS, RM/SM (NRCM), CISS-RAD
Scientific Competency Expert
Martell Winters is a specialist microbiologist (NRCM) and a radiation specialist (AAMI). He has been at Nelson Labs for 24 years and spent his earlier years working in the Radiation Sterilization group, responsible for bioburden testing and radiation validation studies. His specialties include microbiological process validation and radiation sterilization of medical devices, allograft tissue, and pharmaceutical products.