Who's On Your Clinical Evaluation Report Team?

As organizations grapple with the challenges of developing an EU MDR-compliant Clinical Evaluation Report (CER), the first question after “What is a CER?” is usually, “Who will write it?” Assembling the right team with the right skill set is critically important, as your CER must prove to the notified body that you have:

• Reliably established the safety and performance of the device and the state of the art, and
• Clearly articulated the results of post market surveillance.

Achieving these results requires that you perform an intensive process of research into free and paid content resources, establish effective search terms, and otherwise cast a wide net to learn all there is to know about your product in the marketplace.

Set the Stage for a Successful CER

When choosing members of your CER team, consider selecting those who who possess the specialized skills required to quickly and effectively achieve the intentions of the Clinical Evaluation Report. At a minimum, we recommend...

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