Integrating CERs and Post-Market Surveillance

Data inputs, outputs, and everything in between.

Data inputs, outputs, and everything in between.

CEP, CER, PMS Plan, PMS Report, PSUR and SSCP: With a variety of new requirements detailed in EU MDR, integrating the clinical, regulatory, and post-market documentation is a difficult and confusing task for both small and large organizations. There are overlapping requirements and consistent information needs to be included in a variety of plans and reports.

R&Q will explain how the data inputs and outputs for these documents are interrelated and provide guidance on how to share information throughout the organization to streamline processes and ensure consistency.

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