a fragmented CD symbolizing software segregation a fragmented CD symbolizing software segregation
Medical Software - Updated: 2020/01/06 - 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 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. 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.
2019/07/11 - Medical Software - Updated: 2020/09/10 - 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 . 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: 2020/01/06 - 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 . A woman wearing a coat, a hat and sunglasses, standing in front of a desk with a locked file on it. Symbolizing trade secrets .
Regulatory Affairs - Updated: 2020/05/20 - 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 . Silhouette of a doctor, the head filled with bits and a chip, symbolizing artificial intelligence in medicine .
2019/05/02 - Artificial Intelligence - Updated: 2019/11/29 - 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 A folder with the elements lock (=cybersecurity), law, workflows, GDPR, Data and UDI floating into it, symbolizing Technical Documentation

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!

A person working on a computer, Numbers 1 and 0 floating into a green lock, in the background a medical examination table and an American flag, in the foreground a medical kit; symbolizing healthcare cybersecurity . A person working on a computer, Numbers 1 and 0 floating into a green lock, in the background a medical examination table and an American flag, in the foreground a medical kit; symbolizing healthcare cybersecurity .
2019/04/04 - Cybersecurity - Axel Wirth

Healthcare Cybersecurity – the U.S. Perspective

Healthcare cybersecurity in the U.S. encounters basically the same threats as everywhere but unique challenges apply as well.

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: 2020/05/25 - 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.