Medical Device Safety in the
Magnetic Resonance Environment
CDRH’s Recent Draft Guidance Explained

Thursday, June 18, 2020 • 1:30 p.m. - 3:00 p.m. EDT

The expectations for medical device manufacturers around magnetic resonance (MR) safety has changed. The current guidance, implemented in March 2016, covers only passive devices. A new draft guidance is expanded to encompass an even greater spectrum, including ones that are implanted and remain with the patient, like external infusion pumps.

These shifts mean covered devices may be safer ⁠— but they also mean you’ll need to understand a new set of complicated guidelines. Let FDAnews help make that easier.

This webinar will cover how the draft guidance considers hazards in the MR environment, what to include in a hazard analysis, and which standards must be followed to demonstrate device safety. On top of that, we’ll discuss how to best document your results and the importance of accurate safety labeling.

Are you wondering whether your device is now covered? Trying to understand what steps you need to take to ensure your device’s safety and appropriate classification? Deciding how to format your pre-market submissions?

For professionals with a basic understanding of medical device risk management and safety in the MR environment, this webinar will share new knowledge around these shifting requirements and help you determine how you and your team should tackle these steps.

Dan O’Leary, president of Ombu Enterprises, LLC, will discuss the changes brought about by the Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment draft guidance. He will dig into the issues this new guidance raises, navigating its complex requirements, and how using these expectations for managing risks can lead to safer devices.

Key Webinar Takeaways:

  • The New Scope of Draft Guidance
    1. Expansion to more medical devices
  • Hazards in an MR Environment
    1. Application of ISO 14971:2019 to MR environment hazards
    2. Product safety standards in the context of ISO 14971:2019
  • Preparing MR Reports and Their Use in Pre-Market Submissions
    1. Additional necessary details
    2. Suggested submission formatting
  • Performing MR Safety Classifications
    1. Three types of classifications: MR Safe, MR Conditional, MR Unsafe
    2. The necessity of labeling
    3. Usability engineering
  • Impacts on the Global Unique Device Identification Database

    There’s no ignoring the new expanded guidelines arounds hazards and safety in an MR environment. Make sure your devices are covered, safe, and appropriately documented. Join us by registering today.

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    Who Will Benefit

    • Medical device manufacturers
    • Quality and risk managers
    • Quality, manufacturing, and design engineers
    • Production managers involved in process changes
    • Audit Committees focused on compliance and investigations
    • Regulatory affairs staff


    Meet Your Presenter

    Dan O’Leary

    Ombu Enterprises, LLC

    Dan O’Leary, president of Ombu Enterprises, LLC, has over 30 years of experience in quality, operations, and program management in regulated industries, including aviation, defense, medical devices, and clinical labs. His group, Ombu Enterprises, offers training and execution in operational excellence, focusing on analytical skills and a systems-centered approach to operations management. O’Leary has a master’s degree in mathematics and is an ASQ-certified biomedical auditor, quality auditor, quality engineer, reliability engineer. He is also certified by APICS in resource management.

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