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Wendy Mach

Wendy Mach

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 four years as a lab supervisor, managing the sterility, microbial limits, bioburden, endotoxin, and antimicrobial effectiveness services. In 2004 Wendy moved to Salt Lake City to accept a position in the EO department at Nelson Labs and was responsible for sterilization D-value and packaging microbial aerosol challenge studies. In her current role she is the senior manager for Expert Advisory Services and is associated with hospital reprocessing, packaging, and microbiology services.

She is a participating member on the Technical Committee ISO/TC 198 Sterilization of Health Care Products, the subcommittee chairperson for ASTM F02.15 Chemical/Safety Properties, and the chairperson for the packaging workgroup of the Society for Sterility Assurance Professionals (SfSAP). Wendy’s participation in the domestic and international committees allows her to consult with clients so that they meet the regulatory standards of today and, furthermore, that they meet the demands of the future.