The European notified bodies take the clinical evaluation of medical devices very seriously and require up-to-date clinical evaluation reports (CERs) for a medical device to obtain a CE marking. But, as the evaluation of a medical device is not a snapshot but a continuous process that can require nearly unlimited amount of information, it can feel like an impossible task to plan for, write, and maintain a CER.
Avania’s expert medical writing team and comprehensive CER solutions will quickly advance your product to the next milestone. Whether you need a writing team to write the CER for you or are looking for support throughout the CER process, we are here to help.
Download our fact sheet now to learn more about the clinical evaluation process and what Avania can do for your CER.