Medical Software

2020/12/09 - Medical Software - Cord Schloetelburg

Medical apps or software: classification and approval as medical device

Software like a medical app that has a medical purpose is legally a medical device. This article gives an overview of the path from a software to a medical device with CE-marking.

2020/12/04 - Medical Software - Cord Schloetelburg

Software Life Cycle for Medical Devices: IEC 62304

In this article, we discuss what manufacturers must pay attention to when considering the software lifecycle and how the standards specifically help in this respect.

a fragmented CD symbolizing software segregation a fragmented CD symbolizing software segregation
Medical Software - Updated: 2021/04/16 - 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.

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 . 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 .
Medical Software - Updated: 2021/04/16 - 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 Opening Doors, a sign with the US flag and the word "Store", inbetween the opening doors a cd with sparkles, symbolizing US Market Access
Medical Software - Updated: 2021/04/16 - 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. 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!

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).

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

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.