AAMI’s Quality Systems suite will provide you with the tools and knowledge you need to manufacture your medical device in compliance with FDA and international standards requirements.

 

 

 

 

 

 

 

 

 

 

The Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485: Navigating Regulatory Requirements 

(Aligned with the FDA's planned focus on the standard 13485:2016)

Learn how to develop and maintain a quality system program that conforms with the FDA’s Quality System Regulation (21 CFR 820) and ANSI/AAMI/ISO 13485:2016. Course content 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 ISO standards development teams.

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Design Control Requirements – Integrating the Quality System Regulation and ANSI/AAMI/ISO 13485

(Aligned with the FDA's planned focus on the standard 13485:2016)

Benefit from an intensive focus on design control requirements for the FDA’s Quality System Regulation, 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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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.

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Integrating Risk Management into the Product Lifecycle: Quality and 13485

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. Present
throughout the course, FDA representatives outline expectations for submissions and compliance, as well as how to apply risk management principles to various aspects of a quality system.

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Corrective and Preventive Action Requirements and Industry Practice

Experience intensive coverage of the elements of the corrective and preventive action (CAPA) system. Learn the purpose of a CAPA system; its integration throughout a quality management system;appropriate data sources and how to coordinate, analyze and manage them; methods for verifying and/or validating actions; writing good CAPA plans; the use of rsk management in conjunction with the CAPA system; and 21 CFR and ISO 13485 requirements.

Risk Management and Human Factors - Coming Soon! Sign-up to receive detailed information and upcoming course dates.