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Medical device safety and risk management

No Shortcuts: Building Out the Right Processes to Ensure Medical Device Safety and Security

EMERGO BY UL SUMMARY OF KEY POINTS:

  • Regulatory focus on medical device safety and risk management intensifying;
  • Functions such as clinical research, post-market surveillance and ISO 14971 compliance should bolster safety and risk management efforts;
  • More robust safety and risk management processes to help medical device companies pivot faster when regulators change requirements.