Medical Device Clinical Trials
Medical device clinical trials are completely new regulated under the EU MDR. Manufacturers are faced with new challenges.
2019/01/03 - Regulatory Affairs - Cord Schloetelburg
Medical Device Certification Based on the New EU MDR: a Step by Step Guide
Medical device certification is a prerequisite for market access in Europe. Use this checklist to start certification based on the new EU MDR.
2019/01/03 - Medical Software - Thorsten Prinz
Guidance for Medical Software Companies
You have to do with medical software and feel lost in regulation? Don’t give up. Get guidance with our latest book.
