VDE Medical Devices and Software

Person with a broken leg and a broken arm, money flying around him, symbolizing product liability with medical devices Person with a broken leg and a broken arm, money flying around him, symbolizing product liability with 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.

Sheet of paper with a magnifying glass, showing a scale in the glass. It symbolizes the conformity with the law in harmonized standards Sheet of paper with a magnifying glass, showing a scale in the glass. It symbolizes the conformity with the law in harmonized standards
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.

European flag with scale symbolising CJEU European Court of Justice European flag with scale symbolising CJEU European Court of Justice
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).

A hospital in the background, a patient and a medicin in the foreground and a big datasheet, symbolizing Medical Device Clinical Trials A hospital in the background, a patient and a medicin in the foreground and a big datasheet, symbolizing Medical Device Clinical Trials
2019/01/04 - Clinical Affairs - Updated: 2021/04/16 - Thorsten Prinz and Helene Kern

Medical Device Clinical Trials

Medical device clinical trials are completely new regulated under the EU MDR. Manufacturers are faced with new challenges.

footsteps towards a sign saying ce, symbolizing step by step guide to EU CE medical device certification footsteps towards a sign saying ce, symbolizing step by step guide to EU CE medical device certification

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.

Compass and a person working an computer, symbolizing Guidance for Medical Software Compass and a person working an computer, symbolizing Guidance for Medical Software

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.

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