About
Kevin Gunning is a Quality Management Systems expert, with over 25 years of experience in highly regulated industries, including medical device, biotech, pharmaceutical, and CLIA laboratories. He has worked with companies ranging from first year start-ups to large, multi-national pharma and device companies. His specialty is implementing quality system processes that are lean, deterministic, and right sized to fit each organization’s current requirements, personnel, and risk profile.
Mr. Gunning has a bachelor's in biology from SUNY @Buffalo and is an ASQ-certified Quality Auditor. He lives in the San Francisco Bay Area, California.
Regulations and Standards:
ISO 9001:2015
US FDA QSR / QMSR, 21 CFR Part 820
ISO 13485, ISO 14971, ISO 62304, ISO 62366
EU MDR (2017/745) and IVDR (2017/746)
US FDA cGMP, 21 CFR Part 210/211 (drugs), 600-680 (biologics), Part 58
ICH Q10 Pharmaceutical Quality System
CLIA (42 CFR Part 493), ISO 15189, CAP, CLSI QMS01
“Sound QMS process design is the fundamental driver of product quality and customer satisfaction.”