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.

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