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

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 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
2019/01/21 - Risk Management - 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?

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 . 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 .
2019/01/11 - Regulatory Affairs - Updated: 2021/04/16 - 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.

2019/01/11 - Clinical Affairs - Updated: 2022/03/14 - 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.

2019/01/10 - Consulting

About VDE Medical Devices and Software

MeSo stands for Medical Devices and Software. Find out why the VDE provides this platform.

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). 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).
2019/01/10 - Medical Software - 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.

A shild with an eye on it, symbolizing GDPR principles A shild with an eye on it, symbolizing GDPR principles
2019/01/09 - Medical Software - 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.

Person with a broken leg and a broken arm, money flying around him, symbolizing product liability with medical devices Person with a broken leg and a broken arm, money flying around him, symbolizing product liability with medical devices
2019/01/09 - Medical Software - Cord Schloetelburg and Boris Handorn

Product Liability and Medical Software: Fortunately You Can Insure Yourself

Software can be a medical device. This has considerable consequences for product liability. The good news: manufacturers can manage the risks.

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