2019/01/08 - Regulatory Affairs - Cord Schloetelburg
EU MDR Factsheet for Manufacturers of Medical Devices
Medical device manufacturers must implement the new EU MDR. Here you will find an overview to get things going.
2019/01/08 - Regulatory Affairs - Thorsten Prinz
Transition Period of the EU MDR: What Dates Manufacturers Need to Know
The new EU MDR is complex and challenges the manufacturers. We explain what you need to pay attention to in the transition period.
2019/01/07 - Medical Software - Updated: 2021/04/16 - Thorsten Prinz
Harmonized Standards for Medical Software
Harmonized standards are the first choice to achieve conformity with the EU MDR, but not all requirements are always covered.
2019/01/07 - Regulatory Affairs - Updated: 2021/04/16 - Thorsten Prinz
CJEU Top Court Cases on Medical Devices
Regulatory requirements are also based on the interpretations of the legal framework by the European Court of Justice (CJEU).
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.
