Silhouette of a doctor, the head filled with bits and a chip, symbolizing artificial intelligence in medicine .
Published: 2019/05/02 - Guidance - Updated: 2019/07/08 - 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 - Guidance - 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!

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 .
Published: 2019/04/04 - Guidance - by 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.

A lamp, a doctor and a a lying man, seeing his brain, symbolizing neurosurgery

In-Clinic Workshop “Neurosurgery for Engineers”

Learn from neurosurgery doctors what their challenges and expectations are concerning medical devices in the clinical environment.

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 - Guidance - Updated: 2019/06/07 - 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.

In the foreground a hand above a red button, in the background an MRI with some bolts around it, symbolizing dangerous error condition. The whole image symbolizes Risk Management for Medical Devices.
Published: 2019/03/04 - Guidance - by Hans Wenner

Risk Management for Medical Devices

Risk management in medical devices is an important contribution to patient safety. But how do you perform a risk management. We tell you!

A monitor showing white outlines of a brain on a black background, symbolizing Medical Imaging
Published: 2019/02/19 - User Experiences - by Mortimer Gierthmühlen

Medical Imaging Software – What Clinicians need

Medical imaging software is developed for clinicians. Do you know what requirements these professional users have? Here a user tells you!

A shield in with a lock on it in the foreground, 0 and 1 in the background, symbolizing cybersecurity principles in software
Published: 2019/02/05 - Guidance - Updated: 2019/07/16 - by Thorsten Prinz and Daniel Jacobi

Cyber Security Threats in Healthcare

Cyber security threats affect medical device safety and patient protection. Learn here how to perform best regarding risk management.

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