Episode Details

This is the audio-only version of DEVICE LOVE Live! #28, originally recorded February 11, 2021.

The MDR and IVDR have significantly increased requirements for clinical, regulatory, and post-market surveillance documentation. To make it even more challenging, there are overlapping requirements resulting in the need for consistent information across a variety of plans and reports. The integration of clinical, regulatory, risk management and post market surveillance is a difficult and confusing task, however, it's essential to ensure consistent information across all plans and reports: CEP/PEP, CER/PER, risk management file, labeling, PSUR, PMCF/PMPF, and SSCP/SSP.

Our experts will discuss how the data inputs and outputs for these documents are interrelated and provide guidance and best practices on how to share information throughout the organization to streamline processes and ensure consistency.

Amie Smirthwaite, Ph.D. - Head of Clinical Regulatory Affairs, RQM+ Jaishnankar (Jai) Kutty, Ph.D. - Vice President of Clinical Services, RQM+ 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

-

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.

We are passionate about your success. Tell us more about your regulatory and quality needs so we can help.

Book a Consultation

GLOBAL BOTTOM CTA INSTRUCTIONS:

To display custom copy instead of global copy in this section, please go to Show Global Content for Bottom CTA? toggle in the "Contents" tab to the left, toggle it off, save, and then REFRESH the page editor, the custom text will then show up and ready to be edited.

Turning the global content back on will be the same process, go to the toggle and toggle it back on, save and refresh!