Medical Software - by Cord Schloetelburg

Software Life Cycle for Medical Devices: IEC 62304

In this article we give an overview of the software life cycle of medical devices and the corresponding standards.

a fragmented CD symbolizing software segregation
Published: 2019/10/11 - Medical Software - Updated: 2019/11/28 - by Georg Heidenreich and Hans C. Wenner

Software Design for Segregation

Segregation is an important strategy in software development for reducing complexity. Find out how to apply segregation to your software!

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 - Medical Software - Updated: 2019/12/05 - 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 - 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 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!

Opening Doors, a sign with the US flag and the word "Store", inbetween the opening doors a cd with sparkles, symbolizing US Market Access
Published: 2019/03/21 - Medical Software - Updated: 2019/11/28 - by Thorsten Prinz and Tobias Schreiegg

Market Access for Medical Software in the United States

Market access of medical software in the U.S. is quite different compared to Europe. Get insights about the principles.

A folder with a star on it, containing one document, symbolizing Best Practices in Software Documentation.
Published: 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!

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 - Medical Software - 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.

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