This white paper is a companion piece to our popular webinar where we share some of the biggest issues we have discovered when starting a Clinical Evaluation Report (CER) project. Download this white paper and use the Task List on the final page as part of the CER kick-off meeting to guide your initial scoping activities to help ensure a CER that is MDR compliant.
A CER tells the story of the clinical evaluation process of your device. This story is built with many different components — think Jenga tower. If any one of these components falls through or gets off-track, the entire CER will go with it. Scoping identifies the critical inputs needed for a successful CER and the consequences if those inputs are not available or incomplete.
There’s no substitute for experience. Not just writing experience, but industry experience – collectively, the CE team represents over 4 decades of direct industry experience. The team is among the best in the business. Top-flight, advanced-degree clinical professionals with years of experience writing an array of regulatory reports for medical device manufacturers and pharmaceutical and biologics companies.
To learn more about how Criterion Edge can help you achieve your regulatory goals, see criterionedge.com, or contact the company at info@criterionedge.com or, by phone, at +1-805-202-5520
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