Risk Management for Devicemakers: New Requirements in ISO 14971
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. Order your copy today.
Who Will Benefit
- Quality control unit
- Risk management team
- Regulatory affairs
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