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 These regulations superseded the previous Directives for the European market and will be implemented over the next few years. In this blog, we’ll zero in…

Medical Device

Six Things You Need to Know About Medical Devices and Cybersecurity

Medical Device

Clinical Endpoint Committees: Ensuring the Quality, Validity, and Integrity of Clinical Trial Results

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 standardize outcomes and optimize data quality, ultimately driving study success. A CEC addresses the challenge…