Risk Management for Devicemakers: New Requirements in ISO 14971

Edwin Waldbusser

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How will ISO 14971:2019 impact you as a manufacturer? What will you need to do differently? Will you need to rethink the way you’ve been doing risk management?

You have until December 2022 to fully comply with ISO 14971:2019. If you don’t implement the revised requirements in ISO 14971:2019 and EN ISO 14971:2019 within your risk management system, your devices may not be compliant.

The revision of ISO 14971 published in December 2019 provides new definitions of some key terms and sets several important new requirements, including dealing with data and system security, assessing residual risk acceptability, balancing residual risk with benefit in both the production and postmarket phases and tracing risk throughout a device’s lifecycle.

Risk Management for Devicemakers: New Requirements in ISO 14971 provides all the details on ISO 14971:2019, including:

  • Criteria for risk acceptability
  • Changing your mindset from risk-benefit to benefit-risk and how it is significant
  • How to interpret new definitions of such terms as “state of the art” and “reasonably foreseeable misuse”
  • Developing and documenting a process for determining significant residual risk
  • Risk management review and reporting requirements
  • Verifying the effectiveness of the risk management plan

With Risk Management for Devicemakers you’ll be equipped to manage any required changes to your risk management systems, so you can stay compliant.


Who Will Benefit

  • Quality control unit
  • Risk management team
  • Regulatory affairs
  • Engineering
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Speaker: Edwin Waldbusser, Medical Device

Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the areas of design control, risk analysis and software validation for the past 8 years. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.

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