Traceability - VDE Medical Devices and 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 for Medical Devices: IEC 62304
In this article we give an overview of the software life cycle of medical devices and the corresponding 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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