A monitor showing white outlines of a brain on a black background, symbolizing Medical Imaging A monitor showing white outlines of a brain on a black background, symbolizing Medical Imaging

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 A shield in with a lock on it in the foreground, 0 and 1 in the background, symbolizing cybersecurity principles in software
2019/02/05 - Cybersecurity - Updated: 2020/06/05 - 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.

Skull and crossbones in the background, silhouette of a person in the foreground with green hands above his head, protecting him. The image symbolizes Risk Management according to ISO 14971 Skull and crossbones in the background, silhouette of a person in the foreground with green hands above his head, protecting him. The image symbolizes Risk Management according to ISO 14971

ISO 14971 Risk Management in the Future

Safety risks have always been considered in risk management according to ISO 14971. But what is about upcoming security risks?

A bar code in the background, a pole with direction signs, UDI-DI and UDI-PI written on it, symbolizing the UDI system, enhancing traceability . A bar code in the background, a pole with direction signs, UDI-DI and UDI-PI written on it, symbolizing the UDI system, enhancing traceability .
2019/01/11 - Regulatory Affairs - Updated: 2020/06/05 - Thorsten Prinz and Michael Ankele

Traceability of Medical Devices

Traceability plays a key role in increasing the safety of medical devices. Now, Unique Device Identification (UDI) also applies in Europe.

2019/01/11 - Clinical Affairs - Updated: 2019/11/28 - Thorsten Prinz and Helene Kern

How to Perform Clinical Evaluation of Medical Software

Manufacturers must do a clinical evaluation of a medical device before they can market it in Europe. Find out what you need to keep in mind.

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.

Sheet of paper with a magnifying glass, showing a scale in the glass. It symbolizes the conformity with the law in harmonized standards Sheet of paper with a magnifying glass, showing a scale in the glass. It symbolizes the conformity with the law in harmonized standards
2019/01/07 - Medical Software - Updated: 2019/11/28 - Thorsten Prinz

Harmonized Standards for Medical Software

Harmonized standards are the first choice to achieve conformity with the EU MDR, but not all requirements are always covered.

European flag with scale symbolising CJEU European Court of Justice European flag with scale symbolising CJEU European Court of Justice
2019/01/07 - Regulatory Affairs - Updated: 2019/11/28 - Thorsten Prinz

CJEU Top Court Cases on Medical Devices

Regulatory requirements are also based on the interpretations of the legal framework by the European Court of Justice (CJEU).