How to Hire an EU MDR Literature Search (or CER) Writer and What to Look For With the upcoming transition to the EU MDR ( Medical Device Regulation (MDR) 2017/745) in May 2021, medical device manufacturers are facing constant monitoring and life-cycle management of their clinical data. In the European Union, the Clinical Evaluation Report (CER) is critical [...]
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 [...]
