Product Liability and Medical Software: Fortunately You Can Insure Yourself
Software can be a medical device. This has considerable consequences for product liability. The good news: manufacturers can manage the risks.
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).
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.
