Within our industry, we have seen several approaches to selecting samples sizes, this paper will not cover all of the approaches, but it is a guide to give medical device manufacturers and pharmaceutical companies a good starting point for determining their own ideal sample size.
Selecting & Justifying Sample Sizes: Where to Begin?
RM (NRCM), CQA (ASQ)
Wendy Mach has over 24 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...