AAMI Event: Integrating Risk Management to the Product Life Cycle – February 1 – 3, 2023
This comprehensive 3-day course for medical device manufacturers presents risk management concepts used throughout the quality system that can help your organization meet FDA, ANSI/AAMI/ISO 14971 and ANSI/AAMI/ISO 13485:2016 requirements for risk management. This course [...]
AAMI Event: Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485 – December 12 – 16, 2022
This 4.5 day course is the culmination of years of consensus development on the part of a respected group of quality system experts from leading device manufacturers, the FDA, industry consultants, and members of International [...]
AAMI Event In Person and Virtual – Design Control Requirements – Integrating the Quality System Regulation – November 30 to December 2, 2022
This intensive 3 – day course provides complete coverage of design control requirements for FDA Quality System Regulation, ANSI/AAMI/ISO 13485:2016, and the Medical Device Single Audit Program (MDSAP). With the participation of FDA representatives during [...]
AAMI Event – Sampling Plans-Made Easy – November 16 and 17, 2022
Event Overview To the casual observer, Sampling Plans can be incredible complex and hard to apply. Worse yet, the subject is a jungle with non-intuitive jargon and crazy acronyms. So why bother? The key advantage [...]