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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. 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 Device makers 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
  • Start:April 27, 2021
  • End:April 27, 2021
  • Recurring
  • Where:New York, New York,, New York County, New York, United States, 10000
  • Phone:N/A
  • Event Type: Other
  • Ticket Price:N/A
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