Wendy Mach has almost 30 years of medical device manufacturing, sterilization 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 microbiology tests for sterility assurance and related equipment validations. Mach also spent four years as a lab supervisor, managing the sterility, microbial limits, bioburden, endotoxin and antimicrobial effectiveness services.

Mach is an industry subject matter expert for ship testing, package strength, integrity and microbial barrier tests. She is a participating member of the AAMI Technical Committee ISO/TC 198 Sterilization of Healthcare Products, the subcommittee Chairperson for ASTM F02.15 Chemical/Safety Properties and Chair for the Society for Sterility Professional Packaging WG.