Episode Details

This is the audio-only version of RQM+ Live! #30, originally recorded March 11, 2021.

The first and arguably most critical step in the IVDR implementation process is determining if you have a compliant intended purpose statement. This has proven to be challenging, even for legacy devices, and has already resulted in notified body findings for manufacturers who are getting a head start over others in the industry.

It's important the intended purpose statement be compliant while also serving the business strategy. Considerations are:

Does the statement meet the definition of an IVD device under IVDR? Is the statement consistent with the classification of the device under the IVDR? Is there sufficient clinical evidence and performance data to support the statement? Will gathering additional data cost more than it's worth to market the product? Does the statement support what patients need? Is the statement narrow enough for regulators to accept it given the clinical evidence? Is the statement flexible enough for payers and providers?

In this show our IVDR experts will discuss strategies for developing intended purpose statements, evidence and a compelling story to tie it all together, so that you can continue to market your IVD under the IVDR.


Nancy Morrison, RAC - Executive Director, Regulatory and Quality Consulting Services Jon Gimbel, Ph.D. - Executive Director, Regulatory and Quality Consulting Services Celeste Maksim, Ph.D., RAC - Senior Manager, PMS and PMCF Services Ron Sills - Senior Principal Specialist Paul Briest - Operations Manager / Principal Engineer


About RQM+

RQM+ is the world's leading medical device and diagnostics focused regulatory and quality consulting firm. We deliver transformative solutions by providing an unrivaled collective expertise, fueled by passion for client success. Our experts are collaborative, laser-focused on client needs, and committed to delivering high value solutions that exceed expectations. Learn more at RQMplus.com.

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