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R&Q Webinar: What is sufficient clinical evidence to meet the EU MDR?
February 26 @ 1:00 pm - 2:00 pm
Join BioOhio member R&Q for the webinar What is sufficient clinical evidence to meet the EU MDR? on February 26 at 1 pm.
The EU MDR lays out requirements for a proactive post-market surveillance system that inputs into the ongoing risk management and clinical evaluation processes throughout the device lifecycle. This session will address the expectations for sufficient clinical evidence and the opportunities, risks, and challenges associated with each. Additionally, we’ll cover requirements for PMS planning and PMS reporting for all classes of devices. With significant new requirements for device-specific plans and reports, you’ll need to update your post-market surveillance system with enough time for your staff to implement the changes. The requirements seem to overlap with the CER requirements and risk management activities.
How can you optimize your processes to avoid duplication of efforts and maintain consistency throughout your quality management system? Are you really ready?
Who should view?
This session is designed for regulatory, quality, and supply chain representatives.