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GMED North America’s Training Center

Risk management applied to Medical Devices (ISO 14971:2019)

Understand the requirements for implementing a successful risk management system
2-day training session | Virtual Classroom

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About the training

Risk management goes beyond development and manufacturing; it is a vital part of all your company’s processes. ISO 14971 defines the international requirements of risk management systems for medical devices, defining best practices throughout the entire life cycle of a device.

To ensure your company gets a safe, effective product to market on time and within budget, you need a successful implementation of your risk management system.

With the newly updated ISO 14971:2019 standard, GMED North America has created a 2-day training session, to equip medical device manufacturers with the right understanding and implementation of the Risk Management for Medical Devices – ISO 14971:2019.


  • General knowledge of Risk Management for Medical Devices principles
  • Global knowledge of the European Medical device regulation: Directive 93/42/EEC and regulation (EU) 2017/745.


Amy ChanAmy Chan

Product Reviewer, GMED North America


Amy is a medical device professional with 15 years of extensive experience in the pharmaceutical and medical device fields. She has worked as an engineer in research and development, manufacturing, and quality assurance at renowned medical device companies. In these roles, she has served as a pivotal part in facilitating the market entry of innovative and life-saving medical devices. For the past 5 years, Amy has worked as a product reviewer at notified bodies specializing in the review of non-active cardiovascular devices. Amy is currently a product reviewer in Cardiology at GMED North America. Amy holds a Master’s degree in Bioengineering from University of California, San Diego.

Adam BarlettAdam Barlett

Certification Project Manager and Product Reviewer, GMED North America


Adam is an expert in product development and risk management for orthopedic medical devices, with over 8 years of experience in end-to-end development for globally sold products. He has played a key role in developing implants and instruments for treating and reconstructing joints, addressing hip, knee, extremity, sports medicine, and trauma needs. As a Certification Project Manager at GMED North America, Adam guides clients through ISO 13485:2016, MDSAP, Medical Device Directive 93/42/EEC, and Medical Device Regulation 2017/745 audits and evaluations. He is also a qualified reviewer for non-active orthopedic implants and non-active, non-implantable instruments undergoing MDR evaluation.

Who Should Attend

  • Regulatory Affairs Managers
  • Quality Managers
  • R&D and Manufacturing Managers
  • Internal and external Auditors

Learning Objectives

  • Know the standard’s vocabulary and principles
  • Understand the purpose, structure, and key concepts of ISO 14971
  • Know the risk management methodology for medical devices described in standard EN ISO 14971
  • Understand the risk management approach through regulation

Educational Resources

  • Presentations
  • Practical working sessions
  • Course evaluation

Check out the Program

Day 1 & 2
  • Objectives of ISO 14971 standard and associated vocabulary
  • Standard General requirements
  • Standard Methodology (different steps)
  • Risk Management and usability
  • Risk Management within the EU Medical Device Regulation
  • ISO 13485 requirement – risk management approach
  • Practical working sessions
  • Group workshop
  • Course Evaluation
  • Summary and Discussion with the trainer
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