A hand holding a sheet with an exclamation mark and a list, a red cross in the background. Symbolizing a Factsheet for the EU MDR.
Published: 2019/01/08 - Guidance - by Cord Schloetelburg

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.

Person standing, having a a folder with a scale symbol on it, in his hands. In the background some shelves with many books on it. Altogether symbolizin a person taking care of the legal requirements and most importent documents for market access of medical software.
Published: 2019/07/31 - Guidance - Updated: 2019/08/15 - by Thorsten Prinz

Legal Requirements for Medical Software

Our resources of legal requirements for medical software help you to find all important laws, guidelines, and standards.

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 - Guidance - Updated: 2019/07/11 - 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 - Development - 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 - Guidance - 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 - Guidance - Updated: 2019/07/04 - 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 patient with an ECG, a nurse and a doctor standing behind him, symbolizing Emergency Medicine cases

In-Clinic Workshop “Emergency Medicine”

In our workshop you learn from physicians what is needed for successfully developing medical devices for emergency medicine and radiology.

A patient sending mail, a scientist sending literature, a company sending data and a doctor sending blood samples or laboratory results to a company, symbolizing clinical evaluation according to MEDDEV

Clinical Evaluation of Medical Devices

Learn in our workshop how to be compliant with the MEDDEV guideline and MDR requirements for clinical evaluation of your medical device.

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