Quality Systems

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.

Featured Courses

Quality Systems and Risk Management

Quality System Regulation 21 CFR 820 & ANSI/AAMI/ISO 13485

Our flagship course on quality systems
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Quality Systems and Risk Management

Process Validation Requirements & Industry Practices

Practical tools and techniques for process validation requirements for FDA’s Quality System Regulation
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Quality Systems and Risk Management

Validation of Analytical Procedures - Made Easy

Suppose you have a complex piece of laboratory equipment, or you are manufacturing a diagnostic medical device. A critical question is: “How do you know that you can trust measurements from those instruments?” This webinar will provide a working knowledge of Validation of Analytical Procedures. This very valuable statistical methodology is essential for laboratories and certain diagnostic medical devices. 

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CAPA  - Corrective and Preventative Action Requirements Medical Device Manufacturing and Design Training

Quality Systems and Risk Management

CAPA: Corrective and Preventive Action Requirements and Industry Practice

Year after year, one of the top reasons cited by the FDA in 483s is “lack of or inadequate procedures” for CAPA. This course will give you the knowledge you need to eliminate warnings due to CAPA-related issues.
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Quality Systems and Risk Management

Purchasing Controls and Supply Chain Management

During this 2.5-day course, you’ll learn how to evaluate your organization’s compliance with FDA requirements for purchasing controls and acceptance activities, consider appropriate risk mitigation strategies for supplied products and services, and implement a life cycle management approach to your organization’s supply chain.
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Quality Systems and Risk Management

Design Control Requirements - Integrating the Quality System Regulation

This highly interactive course engages the learner with in-depth discussion of industry best practices to learn how industry leaders address design control challenges.
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Quality Systems and Risk Management

Integrating Risk Management into the Product Life Cycle

This course covers the use of risk management principles throughout the life cycle of the product.
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Upcoming Events

Expert Insights

FMEA Without Tears (March 2024)

Mar 26 to Mar 26, 2024

Regulatory

Key Updates: AAMI TIR48:2023 – QMS Recommendations for Combo Products (Mar 2024)

Mar 27 to Mar 27, 2024

Process Validation Requirements & Industry Practices (April24)

Apr 9 to Apr 11, 2024

Quality Systems

Quality System Regulation 21 CFR 820 & ANSI/AAMI/ISO 13485 (April24)

Apr 15 to Apr 19, 2024

Quality Systems

Design Control Requirements - Integrating the Quality System Regulation (May24)

May 1 to May 3, 2024

Quality Systems

Purchasing Controls & Supply Chain Management (June24)

Jun 3 to Jun 5, 2024

Regulatory

Combination Products: A Risk-Based Approach (June 2024)

Jun 4 to Jun 6, 2024

Quality Systems

Corrective & Preventive Action Requirement & Industry Practice (Jun24)

Jun 6 to Jun 7, 2024

Quality Systems

Design Control Requirements - Integrating the Quality System Regulation (July24)

Jul 16 to Jul 18, 2024

Process Validation Requirements & Industry Practices (Aug24)

Aug 5 to Aug 7, 2024

Quality Systems

Quality System Regulation 21 CFR 820 & ANSI/AAMI/ISO 13485 (Aug24)

Aug 19 to Aug 23, 2024

Sterilization

Ethylene Oxide Sterilization for Medical Devices (Aug24)

Aug 26 to Aug 29, 2024

Quality Systems

Design Control Requirements - Integrating the Quality System Regulation (Sept24)

Sep 10 to Sep 12, 2024

Continuing Exploring