ASQ CERTIFIED MEDICAL DEVICE AUDITOR (CMDA) REFRESHER COURSE
Offered by San Gabriel ASQ
Saturdays - March 15 – May 24
Instructor Upen Patel will cover key topics related to ASQ’s Certified Medical Device Auditor (CMDA) body of knowledge through then (10) Saturday sessions.
Topics covered include: Auditing Fundamentals, Auditing and Inspection Processes, US Laws: QSR: CFR Title 21, U.S. requirements (FD&C Act), QSR, EU MDR, Health Canada, Other international agencies, International Standards, Validation, Risk Management, Restriction of Hazardous Substances (RoHS), Human factors and usability engineering, Biological evaluation, Packaging, ...