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speciality

Risk management according to EN ISO 14971:2012 (RM14971)


Description
This 1 day training course gives participants an in-depth knowledge of EN ISO 14971 requirements and its application.
It guides organisations through the regulatory requirements all type of devices, active or non-active sterile devices.
It is making the link with MDR and MDD requirements and explains how businesses can guarantee safety claims of medical devices.
Content
  • Module 1- introduction
  • introduction
  • Module 2-risk management plan
  • Risk management plan example
  • risk management plan
  • Exercise-Risk management plan
  • Module3- risk analysis FMEA part 1
  • Module 3- FMEA part 2
  • FMEA example
  • FMEA
  • Exercise FMEA
  • Module 4- risk management report
  • Risk management report example
  • risk management report
  • Exercise-Risk management report
  • Module 5-Conclusion
  • conclusion
Completion rules
  • All units must be completed
  • Leads to a certificate with a duration: Forever
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