10 Important Tips When Writing a Clinical Evaluation Report (CER) for Medical Devices
A clinical evaluation report (CER) is a vital document that combines both pre-market and post-market clinical data of a medical device. The CER should provide essential information on the safety, performance, and clinical benefit and is a requirement for medical…
How To Classify Your Medical Device Under the EU MDR 2017/745
Did you know that under the EU MDR 2017/745, you now have to reclassify your medical device… even though it was previously classified under the old Medical Device Directive (MDD 93/42/EEC)? If you want to learn about classifying your medical…
How to Comply with the General Safety and Performance Requirements (GSPR)
In today’s post we’re talking about the General Safety and Performance Requirements (GSPR) under the new European Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746). If you are a manufacturer trying to transition to the new…
Scientists Sanctuary 