Episode Details

This is the audio recording from our panel discussion at the MassMEDIC Mid-Year FDA Update event held on April 20, 2021. You can watch the panel discussion here. RQM+ is an Associate Member of MassMEDIC and is sponsoring their FDA series this year (look for another event in December). We're always delighted to collaborate with the team at MassMEDIC.

FDA Submissions in 2021: How's it going?

With a focus on FDA regulatory submissions, this panel discussion will provide context for what occurred in 2020 and early 2021, and provide forward-looking guidance and expectations for the remainder of the year. Will the rest of 2021 be smooth sailing or is there turbulence ahead? Our panel of esteemed regulatory experts, including former FDA CDRH representatives and regulatory leaders from multi-national medical device manufacturers, will discuss their thoughts on FDA focus areas, new guidance documents, and requirements on the way, along with the continued impact of COVID-19 on FDA resources and submission timelines. They’ll also react to FDA Director of the Center for Devices and Radiological Health Jeff Shuren’s presentation being held immediately prior.

The panel includes:

  • Judith E. O’Grady, RN,MSN,RAC – Corporate Vice President Global Regulatory Affairs, Integra LifeSciences
  • Emilia Gonzalez – Global Manager, RA/QA, MIM Software Inc.
  • Elijah Wreh – Elijah Industry Representative for FDA Neurological Advisory Committee Device Panel and Regulatory Affairs Manager, Zimmer Biomet
  • Nancy Morrison – Executive Director of Regulatory and Quality Consulting Services, RQM+
  • Kevin Go – Senior Engineer, RQM+ (Former CDRH Lead Reviewer)

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