Intended Purpose • VDE Medical Software

The intended purpose describes the use as specified by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements and as specified by the manufacturer in the clinical evaluation.

Software Classification: Insights in EU Guidance
The MDR caused uncertainty concerning software classification. We give you an exclusive insight into the upcoming EU guideline!
Risk Classification of a Medical App
Risk classification for medical apps has changed significantly with the European Medical Device Regulation. We give you an example!
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.
ISO 14971 Risk Management in the Future
Safety risks have always been considered in risk management according to ISO 14971. But what is about upcoming security risks?
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.

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