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Even for experienced medical writers and regulatory staff, writing a compliant clinical evaluation report (CER) for medical devices can be tricky. Regulations…

The regulatory landscape in Europe is changing. In 2021, the new medical device regulation was implemented; in 2022, it was time for…

Implementing the MDR or Medical Device Regulation will bring significant changes to the process of Clinical Evaluation and subsequent post-market compliance requirements.…

With the updates to the European Medical Device and In Vitro Diagnostic Device Regulations (MDR 2017/745 and IVDR 2017/746, respectively), the requirements…

Clinical trials are a crucial piece of launching a medical device. Publishing the data you have gathered regarding the safety and effectiveness…

Introduction Clinical trials are a fundamental component of medical product development, providing a controlled environment to evaluate the safety and performance of…

EU MDR Clinical Evaluation Requirement – Understanding the CER A critical component of the Technical File Submission for the CE Marking /conformity…

The literature review is a critical part of any clinical evaluation. It's where you collect all of your clinical data, analyze it,…