China GMP and ISO 13485: A Side-by-Side Comparison
In this member briefing recorded in June 2026, Scott Sardeson walks through his comparison of China’s revised GMP and ISO 13485:2016, highlighting the key areas of alignment and divergence.
Speaker Bio
Scott Sardeson is an adjunct faculty member at St. Cloud State University where he teaches graduate courses on Quality Management Systems in the Master of Science program for medical devices. He also serves as the convener of ISO/TC 210 Working Group 1 that is responsible for ISO 13485:2016.Previously, Scott served as International Regulatory and Quality Compliance Director at 3M Health Care for 19 years.