A folder with a star on it, containing one document, symbolizing Best Practices in Software Documentation.
Published: 2019/02/04 - Guidance

Software Documentation: Best Practices

Software documentation can meet regulatory requirements although it is based on an agile development process. Our video will show you how!

Skull and crossbones in the background, silhouette of a person in the foreground with green hands above his head, protecting him. The image symbolizes Risk Management according to ISO 14971
Published: 2019/01/21 - Standard - by Hans Wenner and Thorsten Prinz

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?

VDE Health

Event Medical Software

In May 2019 the medical software community came together at the VDE Medical Software Event. Save the date: May 13, 2020.

A bar code in the background, a pole with direction signs, UDI-DI and UDI-PI written on it, symbolizing the UDI system, enhancing traceability .
Published: 2019/01/11 - Guidance - Updated: 2019/07/04 - by Thorsten Prinz and Michael Ankele

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.

Published: 2019/01/11 - Guidance - Updated: 2019/07/03 - by Thorsten Prinz and Helene Kern

How to Perform Clinical Evaluation of Medical Software

Manufacturers must do a clinical evaluation of a medical device before they can market it in Europe. Find out what you need to keep in mind.

Monitor showing an ECG heartbeat line, a x-ray image of a hand and a graph, symbolizing medical stand alone software or Software as Medical Device (SaMD).
Published: 2019/01/10 - Guidance - by Thorsten Prinz and Isabel Jakobs

Stand-Alone Software as Medical Device

Thorough analysis of the intended purpose provides essential evidence for stand-alone software being a medical device on its own.

Tree Model for Classification
Published: 2019/01/10 - Guidance - by Thorsten Prinz and Isabel Jakobs

Medical Device Classification: The Software Special

The EU MDR contains new rules for medical device risk classification. Stand-alone medical software usually ends up in higher classes.

A shild with an eye on it, symbolizing GDPR principles
Published: 2019/01/09 - Guidance - by Cord Schloetelburg and Gerald Spyra

GDPR Principles and Medical Software: Privacy by Design is King

The GDPR is legal basis for data protection in Europe. You should adopt GDPR principles directly into the design of your medical devices.

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