Risk Management
EN ISO 14971

Course Outline Risk management is ever-more important for medical device companies, and it’s a complex process. EN ISO 14971 enables companies to integrate risk management into their existing quality systems and provides a disciplined approach for decision-making and implementation of strategy in this area. The latest version of the standard has given device manufacturers significant challenges in terms of meeting revised harmonisation annexes, and may require them to modify their approach. This practical course provides delegates with the tools and techniques to understand and apply EN ISO 14971 – not just those new to the area, but those who want an update on the latest annexes to the standard (annexes ZA, ZB and ZC). It shows you how to integrate risk management and EN ISO 14971 into your own organisation, and enhance your existing quality systems. You will also learn how to modify your approach – including how to upgrade existing files to comply with the latest version, EN ISO 14971:2012, harmonised to the Medical Device Directives as well as essential requirements relevant to Risk Management from the new Medical Device Regulation.

Topics covered include

  • Overview of the EN ISO 14971:2012 standard, including definitions and terms and the annexes confirming harmonisation to the Medical Device Directives
  • An explanation of the latest annexes ZA, ZB and ZC and how to conduct risk management activities to remain compliant.
  • Essential requirements relevant to Risk Management from the new Medical Device Regulation
  • IMDRF/GHTF Guidance “Implementation of Risk Management Principles and Activities within a Quality Management System.”
  • Lifecycle of Risk
  • Risk Management File & Plan
  • Risk Evaluation—Identification of harms, hazards and hazardous situations, tools and techniques including FMEA, Fault Tree Analysis
  • Risk Control and Reduction
  • Residual Risk Evaluation
  • Risk Report including the risk benefit analysis
  • Production / Post Production Requirements as part of ongoing Post Market Surveillance activities
  • Links to other medical device standards including EN ISO 10993-1 Biological evaluation of medical devices and BS EN 62366 Medical devices usability engineering


  • A solid appreciation of the requirements for risk management
  • A comprehensive understanding of EN ISO 14971:2012 and it’s application
  • Ability to enhance existing systems by the integration of risk management
  • The ability to use risk management techniques within day to day activities
  • Have the skills required to plan, conduct, report and follow-up on risk management activities
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