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  • An Easy to Implement Integrated Risk Management Approach
    Compliant with ISO 14971

  • Hosted By:
  • ComplianceOnline
  • Start:
  • Tuesday - Jul 23, 2013 10:00 AM
  • End Time:
  • Tuesday - Jul 23, 2013 11:15 AM
  • Location:
  • Online
  • This integrated risk management training for medical devices will discuss how to incorporate risk management as per ISO 14971 guidelines in all phases of medical device development. It will highlight the documentation needed to support the decisions made as part of the risk management process.

    Why Should You Attend:

    This webinar will cover all major elements of ISO 14971 and present a methodology for integrating the requirements of this standard into the product development process to ensure that the requirements of the standard are met, and the medical device is designed to be safe and effective. The webinar will specify how risk management activities are incorporated in all phases of development, and what supporting documentation needs to be gathered in order to ensure that decisions made based on what is learned as part of the risk management process are adequately justified and documented.

    Areas Covered in the Seminar:

    - How are risk management activities integrated throughout the development process.
    - The roles that Hazard Analysis, FTA, FMEA, HAZOP and PFMEA play in an Integrated Risk Management Process.
    - How to control and verify risk mitigations.
    - How to perform a Risk Benefit Analysis on ALARP and INTOLARABLE Hazards.
    - The importance of maintaing Risk Management documents in the Post Production era.
    - What information to include in the Risk Management Plan and Report for better auditability.
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