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  • Developing a Post-Approval Risk Management Strategy for
    Medical Devices

  • Hosted By:
  • ComplianceOnline
  • Start:
  • Tuesday - May 28, 2013 10:00 AM
  • End Time:
  • Tuesday - May 28, 2013 11:15 AM
  • Location:
  • Online
  • This medical device risk management webinar will discuss how to develop a Risk Management File in compliance with FDA and ISO 14971 requirements and what FDA will look for in risk evaluation and mitigation strategies (REMS) prior to or post approval of medical devices.

    Why Should You Attend:

    Manufacturers and Study Sponsors must understand the aspects of Risk Management, and how to effectively document their efforts. The Food and Drug Administration Amendments Act of 2007 gave FDA the authority to require a Risk Evaluation and Mitigation Strategy (REMS) from manufacturers or sponsors to ensure that the benefits of a product outweigh its risks. Regardless of whether FDA has made the request it always best to be proactive and have your risk management activities well documented.
    In this webinar, we will discuss how Risk Management Files should be developed in accordance with ISO 14971 and what FDA is looking for in REMS.

    The presenter will explain how any product changes, including labeling, must be evaluated in accordance with your Risk Management procedures. You will also learn, from the presenter's first-hand experience, what the FDA expects during an audit of your risk management procedures.

    Areas Covered in the Seminar:

    - Overview of ISO 14971 Medical devices - Application of risk management to medical devices
    - Discussion of key requirements
    - What written procedures and training are required
    - How to develop Risk Management Files
    - How to apply Risk Management to Post-Approval Labeling Risk Management Strategy
    - Understanding of what auditors expect
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