How to Perform Clinical Evaluation of Medical Software
Manufacturers must do a clinical evaluation of a medical device before they can market it in Europe. Find out what you need to keep in mind.
2019/01/10 - Consulting
About VDE Medical Devices and Software
MeSo stands for Medical Devices and Software. Find out why the VDE provides this platform.
Stand-Alone Software as Medical Device
Thorough analysis of the intended purpose provides essential evidence for stand-alone software being a medical device on its own.
GDPR Principles and Medical Software: Privacy by Design is King
The GDPR is legal basis for data protection in Europe. You should adopt GDPR principles directly into the design of your medical devices.
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.
2019/01/08 - 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.
2019/01/07 - 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).