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.

 

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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.

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    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

     

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    Process Validation Requirements and Industry Practice

    Obtain practical tools and techniques for process validation requirements for the FDA’s Quality System Regulation and recognized process validation guidance from the Global Harmonization Task Force.