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North America’s Training Center

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

2-day training session

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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.

REQUIRED LEVEL

  • 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.
Mohamed Alsaadi LNE Gmed

Mohamed AlSaadi Certification Project Manager/Lead Auditor

Mr. AlSaadi joined the GMED NA Team in 2012 and has been working as a Certification Project Manager /Lead Auditor since then, holding a B.Sc. in Biomedical Engineering. Before joining GMED NA, Mr. AlSaadi, worked in the medical field as a Field Engineer, supplier management and conception. He has been working with medical device manufacturers worldwide, auditing their regulatory and voluntary certification.

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
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Program
  • 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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We serve your passion for progress in the Medical Device Industry

Related Training

European Medical Devices Regulation (EU) 2017/745

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