Traceability • VDE Medical Software

Traceability of medical devices is closely linked to the Unique Device Identification system (UDI system). The aim is a better market transparency and product identification through out the entire life cycle.

Software Life Cycle: How do I meet the Regulatory Requirements?
Development of medical software must follow the life cycle principles. Learn in our workshop how to implement the respective standards.
Market Access for Artificial Intelligence in Medicine
How does current regulation for market access fit with artificial intelligence in medicine? Find out more by a practical example.
Traceability of Medical Devices
Traceability plays a key role in increasing the safety of medical devices. Now, Unique Device Identification (UDI) also applies in Europe.
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.
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.

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