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A disc falling down, bumping on some pins, finally landing in one of the 4 bowls, labelled I, IIa, IIb and III. Symbolizing software classification according to EU MDR.
Published: 2019/07/11 - Medical Software - Updated: 2019/11/28 - by Tobias Schreiegg and Thorsten Prinz

Software Classification: Insights in EU Guidance

The MDR caused uncertainty concerning software classification. We give you an exclusive insight into the upcoming EU guideline!

A person sitting on a desk, surveilled by two cameras, a hand with a stopwatch and another person's hands working on graphs. Symbolizing usability engineering.

Usability Engineering: Regulatory Requirements and Product Optimization

Use and user errors are critical risks of medical devices. Learn in our workshop how to set up an efficient usability engineering.

A smartphone showing the symbols of a microphone, a loudspeaker and a voice recognition software. On the left hand a speech bubble out of face silhouette, on the right side a speech bubble from the smartphone app. Symbolizing increased patient compliance for patient diaries for telemonitoring through speech recognition.
Published: 2019/06/26 - Case Study - by Andreas Rösch and David Schmoldt

Improving Patient Compliance With Speech Recognition

The use of patient diaries for telemonitoring often fails due to a lack of compliance. The use of speech recognition can increase patient compliance.

A hand with a red hose leading to a blood icon, a hand with a smart phone and a diagram and a certificate saying "compliance". Symbolizing MDR compliance for medical apps.
Published: 2019/06/13 - Regulatory Affairs - by Thorsten Prinz

[Video] How to Achieve MDR Compliance for Medical Apps

It’s hard to achieve MDR compliance when developing medical apps. Learn in this presentation how to overcome this hurdle.

A guy showing his hand with some kind of stain on it, a smartphone showing a checkmark. All together symbolizing mole assessment via medical app as an example for risk classification .
Published: 2019/05/29 - Medical Software - Updated: 2019/11/28 - by Isabel Jakobs and  Ulrich Spiegel

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!

A woman wearing a coat, a hat and sunglasses, standing in front of a desk with a locked file on it. Symbolizing trade secrets .
Published: 2019/05/16 - Regulatory Affairs - Updated: 2019/11/28 - by Janine Manke and Daniel Kendziur

Trade Secrets: Protect Your Intellectual Property

You must understand the importance of protecting your trade secrets or the development of your medical software was useless!

Silhouette of a doctor, the head filled with bits and a chip, symbolizing artificial intelligence in medicine .
Published: 2019/05/02 - Artificial Intelligence - Updated: 2019/11/29 - by Thorsten Prinz

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.

A folder with the elements lock (=cybersecurity), law, workflows, GDPR, Data and UDI floating into it, symbolizing Technical Documentation
Published: 2019/04/17 - Technical Documentation - by Thorsten Prinz

Technical Documentation: See the Opportunities, not the Challenges!

The technical documentation of medical devices in the EU must be revised. We tell you what to keep an eye on and how to make it a success!

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