While clinical trials for medical devices have many similarities to those for pharmaceuticals, the regulatory evaluation of devices is distinct from that of drugs – and there are critical differences in the way the device trials are designed and executed....
Expertise: Medical Device 45 results
Medical Device
7 Questions About Clinical Evaluations for MDR
After years in development, the final version of the Medical Device/In Vitro Diagnostic Medical Device Regulations was published in the Official Journal of the European Union on May 5, 2017. These regulations superseded the previous Directives for the European market...
The use of Clinical Endpoint Committees for centralized adjudication of efficacy and/or safety endpoints can help to standardize outcomes and optimize the quality of clinical trial data, driving study success. Some compounds and many devices face the challenge of defining...
Medical Device
CECs: What Are They and Why Does Your Trial Need One?
Also called Endpoint Adjudication Committees, Clinical Endpoint Committees (CECs) are an increasingly common component of drug development and medical device evaluation. A CEC is a centralized decision-making body for safety and efficacy endpoints. The goal of a CEC is to...