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.