Industry Training for Medical Device Manufacturers

Here are the AAMI courses for medical device manufacturers, the FDA, and individuals who work in quality systems.

  • The 2018 registration form is available, download it here.
  • Download the new 2019 Registration form.
  • Bring an AAMI course to your site.  AAMI offers all its Quality System training programs on an in-house basis; learn more here
  • Click on the play button (right), and watch a brief video on our updated QMS course.

Application of Agile to the Development of Medical Device Systems

For many years software development teams have been using Agile Software Development methods, but Agile is not just for software. Agile's Lean Product Development principles also apply to the development of hardware-based products and systems. This 2½-day course goes beyond small-team and software-only applications and demonstrates how Agile practices can be used in the development of medical device systems.

  • September 25–27, 2019, Arlington, VA

Corrective and Preventive Action (CAPA) Requirements and Industry Practice

This 2-day course provides intensive coverage of the elements of a corrective and preventive action (CAPA) system. Some primary topics include: the purpose of a CAPA system and how it is integrated throughout a Quality Management System; appropriate data sources and how to coordinate, analyze and manage them; methods for verifying and/or validating actions; how to write good CAPA plans; how risk management is used in conjunction with the CAPA system; and 21 CFR and ISO 13485 requirements.

  • June 18–19, 2019, Arlington, VA

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

This intensive 3-day course provides complete coverage of design control requirements for FDA 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.

Effective Application of Agile Practices in the Development of Medical Device Software

Upon completion of this 2-day course, participants will be able to evaluate the challenges with the use of Agile practices and be prepared to adapt these practices as needed to ensure the development of compliant, safe, and effective products. This course builds on the concepts in AAMI TIR45:2012, Guidance on the use of agile practices in the development of medical device software.

Ethylene Oxide Sterilization for Medical Devices

This highly interactive 3½-day, advanced course assumes that participants are experienced in working with an established ethylene oxide sterilization process, but are now challenged with ensuring the continued effectiveness and assessing change for the product or process. The program combines classroom lecture with real-life scenarios to illustrate concepts and situational analyses that provide participants with the opportunity to apply what they learn to actual sterilization scenarios. Some of the topics to be covered are: validation and requalification; validation reports, protocols, and documentation; product adoption; troubleshooting; process changes and process equivalency; product release methods; and optimization of sterilization process.

  • August 27–30, 2019, Arlington, VA

Human Factors for Medical Devices

This 3-day course offers participants a comprehensive overview to human factors as it relates to medical devices. It includes regulatory requirements of FDA, specifically the interpretation from the Center for Devices and Radiological Health (CDRH) Human Factors Team, as they relate to human factors, and the process of applying human factors in design controls during the design of a medical device. The course also includes the regulatory perspective of the Center for Drug Evaluation and Research (CDER) and the impact of human factors on pharma.

Industrial Sterilization for Medical Devices

Industrial Sterilization for Medical Devices is a comprehensive 4-day course covering essential information on sterilization technologies and methods, sterilization standards, FDA requirements, critical factors in product design and product release decisions, and much more.

Integrating Risk Management into the Product Lifecycle: Quality and 13485

This comprehensive 3-day course for medical device manufacturers presents risk management concepts used throughout the quality system that can help your organization meet FDA and ANSI/AAMI/ISO 13485:2016 requirements for risk management. This course covers the use of risk management principles throughout the lifecycle of the product, from design…to manufacturing…through post-production to retirement. Instructors will illustrate linkages between the product risk management process and quality system processes. Students will discover how to use regulatory databases to support risk management activities at different stages of the product lifecycle, as well as the use of International Product Safety Standards during risk management activities.

Process Validation for Medical Devices: Requirements and Standards

This 3-day course provides attendees with practical tools and techniques for process validation requirements for FDA’s Quality System regulation, the ISO 13485:2016 Standard and recognized Process Validation Guidance from the Global Harmonization Task Force. The program includes industry best practices and real-life process validation examples. 

FDA and AAMI faculty work together to help the learner to:

  • Determine which processes require validation and develop a Validation Master Plan
  • Develop protocol content to ensure a successful validation
  • Document the results and the resolution of deviations that occur during validation execution
  • Plan for effective monitors and controls for their validated processes
  • Determine the revalidation requirements for product and process changes
  • Planning, Protocol Development, Validation Execution, Monitoring & Control and Revalidation to meet the FDA’s expectations and industry’s best practices

Demonstrate Return on Investment (ROI) to employers by completing and passing the Process Validation post-course test. This optional, one-hour, self-assessment tests your mastery of the course materials and your ability to correctly interpret the Quality System Regulation and ISO 13485 Standard.

Purchasing Controls and Supply Chain Management

This 2½-day course provides extensive information on effective implementation of supplier selection and controls. This detailed course covers the 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 Quality System Regulation, the ISO 13485 standard, risk management considerations, and pertinent Global Harmonization Task Force guidance.

The course also covers life-cycle management approaches for a medical device manufacturing organization's supply chain. The course includes substantial "hands-on" exercises to allow attendees to apply concepts and interact with colleagues, and provides specific industry examples.

  • June 19–21, 2019, Arlington, VA

Software Validation Workshop: Practical Tools & Techniques

This 3-day workshop provides attendees with guidance on designing software validation plans that build confidence in the software and comply with regulatory requirements.The workshop is exercise-driven to allow attendees to apply appropriate validation tools and techniques for embedded device software, off-the-shelf software, and quality system (non-device) software. Case studies on traceability analysis, requirements writing, test designs, and validation planning give examples and possible solutions to validation activities.

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

The regulatory world for quality management systems (QMS) is changing fast. To succeed in today’s global market, the manufacturers of medical devices must understand those requirements. This intensive 4½-day course provides quality system professionals with the information needed to develop and maintain a quality system program that conforms with the FDA's Quality System Regulation (21 CFR 820) and International Organization for Standardization 13485:2016, the international standard that spells out the requirements for regulatory purposes for quality management systems. Course content is the culmination of years of consensus development on the part of a respected group of quality system experts from leading device manufacturing companies, FDA, industry consultants and members of ISO standard development teams for standards such as 13485 and ANSI/AAMI/ISO 14971:2007(R)2016, Medical devices­­-Application of risk management to medical devices.

Radiation Sterilization for Medical Devices

This 3½-day program covers principles, processes, industry best practices, and industry standards in radiation sterilization for medical devices. Some of the topics covered are: FDA expectations regarding successful submissions and inspections, recalls, problem solving, and risk avoidance; scientific theory and principles of radiation sterilization; and the 11137 series radiation sterilization standards.

Regulatory Requirements for Software Validation

This 3-day course focuses on the requirements contained in the Quality System regulation specific to software validation. The course explores the latitude and flexibility of the FDA's expectations and provides conceptual ways to meet compliance requirements. Relevant standards, FDA guidance documents, and other resources will be discussed that assist in determining compliance practices.

  • May 7–9, 2019, Arlington, VA