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27 Apr 2021 • 

Risk Management for Devicemakers: New Requirements in ISO 14971

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Estimated Turnout

100
Visitors

100 Exhibitors

Editions

Apr 2021

Frequency

One-time
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"Webinar on Pharmaceutical Industry"
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 .. Read more 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.

Highlights

  • Changing your mindset from risk-benefit to benefit-risk and how it is significant
  • Developing and documenting a process for determining significant residual risk
  • Risk management review and reporting requirements
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Plianced Inc

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