FDAnews Announces — Medical Device Safety in the Magnetic Resonance Environment: CDRH’s Recent Draft Guidance Explained Webinar, June 18, 2020

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Wondering how one’s device fits into the new Magnetic Resonance environment safety guidelines? Webinar has the expert guidance one needs.

WCG FDAnews

WCG FDAnews

Medical Device Safety in the Magnetic Resonance Environment:
CDRH’s Recent Draft Guidance Explained
An FDAnews Webinar
Thursday, June 18, 2020, 1:30 p.m.-3:00 p.m. EDT
https://www.fdanews.com/mdsafety

The expectations for medical device manufacturers around magnetic resonance (MR) safety have been expanded to include not only passive devices but to encompass all medical devices intended to enter an MR field.

Are the company’s devices now covered? What steps does one need to take to ensure one’s device’s safety and appropriate classification? How should one format the premarket submission?

While these shifting guidelines may mean covered devices could be safer, ⁠they also mean one needs to understand a new set of complicated, intricate requirements. Let FDAnews 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This webinar will cover how the draft guidance considers hazards in the MR environment, what to include in a hazard analysis, and which standards must be followed to demonstrate device safety.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 the results and the importance of accurate safety labeling.

Dan O’Leary, president of Ombu Enterprises, LLC, will share how the changes brought about by the Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment draft guidance has led to opportunities for safer devices. He’ll discuss how to navigate its complex requirements and the best ways to manage risks and document results:

  • The New Scope of Draft Guidance

a. Expansion to more medical devices

  • Hazards in an MR Environment

a. Application of ISO 14971:2019 to MR environment hazards
b. Product safety standards in the context of ISO 14971:2019

  • Preparing MR Reports and Their Use in Pre-Market Submissions

a. Additional necessary details
b. Suggested submission formatting

  • Performing MR Safety Classifications

a. Three types of classifications: MR Safe, MR Conditional, MR Unsafe
b. The necessity of labeling
c. 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 one’s devices are covered, safe, and appropriately documented.

Interested in registering multiple sites?
Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally
to learn about our special multisite discount.

Webinar Details:
Medical Device Safety in the Magnetic Resonance Environment:
CDRH’s Recent Draft Guidance Explained
An FDAnews Webinar
Thursday, June 18, 2020, 1:30 p.m.-3:00 p.m. EDT
https://www.fdanews.com/mdsafety

Tuition:
$287 per site

Easy Ways to Register:
Online: https://www.fdanews.com/mdsafety
By phone: 888.838.5578 or 703.538.7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations

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Michelle Butler
FDAnews
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