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.