Overcoming Challenges with Integrating PMS, CERs/PERs and Risk Management under EU MDR and IVDR

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DEVICE L❤️VE Live! is a biweekly and interactive live show featuring expert panelists discussing timely topics, challenges, and solutions in the medical device and diagnostics industries. The panelists also answer audience questions. Every episode is added to our podcast, too.

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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+

  • Jaishankar (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