AAMI's quality systems training gives medical device design and manufacturing professionals the tools and knowledge to maintain regulatory compliance with all applicable FDA and ISO requirements. Our course content was developed with the guidance of experts from leading device manufacturers, the U.S. Food and Drug Administration (FDA), and members of standards development teams.
Learn how to develop and maintain a Quality System management program that conforms with the FDA’s Quality System Regulation (21 CFR 820) and the international quality management standard, ANSI/AAMI/ISO 13485:2016.
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.
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Process Validation Requirements & Industry Practices (Aug25)
August 5 to 7, 2025Register
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Process Validation Requirements & Industry Practices (Dec25)
December 1 to 3, 2025Register
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.
Learn from industry experts, who will help you understand effective implementation of supplier selection and controls. Each topic is presented from a practical perspective with links to the requirements of the Quality System Regulation, the ISO 13485 standard, risk management considerations, and pertinent Global Harmonization Task Force guidance.
Learn the purpose of a corrective and preventive action (CAPA) system, its integration throughout a quality management system, appropriate data sources and how to manage them, relevant regulatory requirements, and much more.
Join us to develop an understanding of risk management concepts used throughout the quality system to successfully meet FDA, 14971, and 13485 requirements, as well as how to use risk management to make risk-based decisions for product realization from cradle to grave.
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Integrating Risk Management into the Product Life Cycle (Oct25)
October 1 to 3, 2025Register
For virtual training courses, please allow one week for US addresses and two weeks for international addresses for shipping of training materials and devices. If you register within these time frames, AAMI cannot guarantee you will receive material prior to the start of the course. If you have any questions, please email education@aami.org.
Explore the Full Upcoming Schedule of Quality System Trainings and Expert Insights
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Design Control Requirements - Integrating the Quality System Regulation (July25)
July 15 to 17, 2025Register
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Design Control Requirements - Integrating the Quality System Reg. (Costa Rica)
July 29 to 31, 2025Register
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Process Validation Requirements & Industry Practices (Aug25)
August 5 to 7, 2025Register
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Process Validation Requirements & Industry Practices (Costa Rica)
August 12 to 14, 2025Register
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Quality System Regulation 21 CFR 820 & ANSI/AAMI/ISO 13485 (Aug25)
August 18 to 22, 2025Register
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Combination Products: A Risk-Based Approach (September 2025)
September 2 to 5, 2025Register
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Design Control Requirements - Integrating the Quality System Regulation (Sept25)
September 9 to 11, 2025Register
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Integrating Risk Management into the Product Life Cycle (Oct25)
October 1 to 3, 2025Register
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Transitioning to the FDA Quality Management System Regulation (QMSR) (Oct 2025)
October 14 to 16, 2025Register
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Quality System Regulation 21 CFR 820 & ANSI/AAMI/ISO 13485 (Nov25)
November 17 to 21, 2025Register
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Process Validation Requirements & Industry Practices (Dec25)
December 1 to 3, 2025Register
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Design Control Requirements - Integrating the Quality System Regulation (Dec25)
December 2 to 4, 2025Register