This white paper covers strategies for the verification of device safety and performance in the clinical evaluation of medical and in vitro diagnostic (IVDs) devices. It should help you with identifying meaningful safety and performance measures for clinical or performance evaluation and with defining acceptance criteria parameters to determine the acceptability of benefit-risk as mandated by Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Regulation (IVDR) 2017/746.
Establishing your device’s safety and performance is a critical component of the clinical evaluation process. However, how to use the state of the art section within the Clinical Evaluation Report (CER) and Performance Evaluation Report (PER) to establish the device's safety and performance objectives and acceptance criteria can seem ambiguous.
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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.