In May 2021, the European Medical Device Directive (93/42/EEC) was replaced with the Medical Device Regulation (MDR, 2017/745). Unlike the MDD, the MDR considers clinical evaluation to take place during the full lifecycle of medical devices, meaning clinical data must be updated continuously. Seeing as clinical data is usually sourced from clinical investigations, post-market [...]
INTRODUCTION A literature search is a deliberate and efficient search from already distributed information to distinguish between a good quality reference on a particular topic. There are different reasons for conducting a literature search, including drawing information for making evidence-based reports, academic assessment, and a step in the research methods. A thorough literature search [...]
Periodic Safety Update Reports: Why You Might Need One Did you know that the Literature Searches you submit for your CE Marking Clinical Evaluation Report might have to be re-run annually? Most that have already submitted an MDR compliant CE Marking Dossier for their products are aware of the need [...]
Cost Savings of Literature Searches in Your CER Introduction We recently had a client that wanted to weigh the option of outsourcing their entire CER project overseas to more attractively priced writing teams. We looked into several firms, and based on our experience with them have priced out the following [...]
