Clinical Evaluation of Medical Devices

Davidbhagya23 Nov, 2020Health

Unlike previous versions, CER Rev 4 has some of the requirements that are very different and just updating based on literature strategy alone will increase your risk of rejection. As Rev 4 needs �Equivalence / Predicate� to be seen from a different perspective, right team of medical, regulatory, technical and scientific disciplines is key to ensure higher quality of CER that�s not only satisfies NBs but also conveys right information to healthcare community.