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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.

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. 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.
2019/03/04 - Risk Management - 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 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.

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!

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.