AAMI Course – Sampling Plans Workshop – February 25, 2021, February 26, 2021, and March 1, 2021 / 1:00 pm – 3:00 pm ET
Sampling a product or process and measuring a quality characteristic is an efficient way to make an inference about the quality of all products or the entire process. Simply put, if it is too expensive [...]
AAMI Course – Integrating Risk Management into the Product Life Cycle – Offered Virtually February 17-19, 2021
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 Course (Offered Virtually) – Integrating the Quality System Regulation and ANSI/AAMI/ISO 13485 – February 8-10, 2021
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 [...]
Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485: Navigating Regulatory Requirements – November 2-6, 2020
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 [...]