Effective March 13, AAMI is transitioning all in-person training courses scheduled through April 30, 2020, to a virtual format. For updates, visit www.aami.org/coronavirus.

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 for Industry Requirements in a Global Market

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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Purchasing Controls and Supply Chain Management

Industry experts will help you understand effective implementation of supplier selection and controls. This course covers key aspects of supplier controls, from planning for supplier assessment/selection, to defining acceptance activities, to monitoring supplier performance.  Each topic is presented from a practical perspective, with links to the requirements of the QSR, the ISO 13485 standard, risk management considerations and pertinent GHTF guidance.

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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.

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Navigating 510k and De Novo Requirements

Do you know how to prepare your own 510(k)? Each year 99% of devices are cleared by the FDA with a 510(k) submission. If you don’t understand the process, your product launch will be delayed by several months. You also need to know when your device is part of the 1% of devices that require a De Novo Classification Request. In this course you will learn how to prepare both types of FDA submissions.

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