ISO 14971- Risk Management of Medical Devices

Created by LEC Team
Last updated Mon, 27-Mar-2023
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 The requirements of ISO 14971 are applicable to all stages of the lifecycle of a medical device. This course helps medical device professionals understand how ISO14971 can improve their business and risk management efforts. The student will gain an understanding of the impact that ISO14971 has on the decision-making process when manufacturing medical devices. After finishing the course, the student will gain the ability to work with risk management for medical devices according to the ISO 14971 standard.

Course Objectives of ISO 14971: Risk Management of Medical Devices

  • Identifying the links between ISO 13485 (QMS) and ISO 14971 (RM)

  • Explaining how risk management relates to the product lifecycle

  • Defining risk management terminology

  • Outlining the stages of the risk management process

  • Defining the key deliverables of the risk management process



Day 1
Introduction to risk management in medical devices

  • Links of risk management to regulatory requirements

  • The relationship of ISO14971 to other standards

  • ISO13485 and Risk Management

  • Understanding ISO13485



Day 2
The development of ISO14971

  • Why do we risk manage medical devices using ISO14971?

  • The Lifecycle approach

  • ISO14971 – Overview of the standard

  • Terms and definitions

  • General requirements of the standard



Day 3
The risk management process

  • The risk management plan

  • Risk analysis

  • Risk evaluation

  • Risk control



Day 4
Residual risk acceptability

  • Report/documentation

  • The Risk Management File Postproduction

  • IEC 606011:2005: Medical Electrical Equipment, General requirements for basic safety and essential performance



Day 5
Tools for Risk management

  • Failure modes and effect analysis

  • Fault tree analysis

  • Hazard analysis and critical control point

  • Summary and conclusions

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