The Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485: Navigating Regulatory Requirements
Learn how to develop and maintain a quality system program that conforms with the FDA’s Quality System Regulation (21 CFR 820) and the international quality management standard, ANSI/AAMI/ISO 13485:2016.
Introduction to Combination Products: A Risk-Based Approach
AAMI is presenting a 6-part online series which will provide learners with an overview of FDA’s and EU's approach to regulation of combination products including review of FDA’s guidance. Topics will cover evolving global combination product regulations; processes to streamline and integrate development of single entity, co-packaged and cross-labeled products.
Design Control Requirements: Integrating the Quality System Regulation and ANSI/AAMI/ISO 13485
Benefit from an intensive focus on design control requirements for the FDA’s Quality System Regulation, the international standard ANSI/AAMI/ISO 13485:2016, and the Medical Device Single Audit Program (MDSAP). With the participation of FDA representatives during the entire course, attendees have the unique opportunity to participate in a shared learning experience.
Integrating Risk Management into the Product Life Cycle
Understand risk management concepts used throughout the quality system to successfully meet FDA, ANSI/AAMI/ISO 14971, and ANSI/AAMI/ISO 13485:2016 requirements. Learn how to use risk management to make risk-based decisions for product realization, from cradle to grave