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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: 2019/11/28 - 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
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.

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

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