CE roadmap for medical devices: What are the requirements for approval and what are the costs?

Every time a medical device is developed, the question comes up at some point which regulatory requirements have to be fulfilled. If the new medical device is to be marketed in Europe, it requires a CE marking, i.e. the requirements of the European Medical Device Regulation (MDR) apply.

Cybersecurity-Risk-Management for Medical Devices: ARGOS

We help you to integrate your cybersecurity management into your risk management. In cooperation with you, we establish fast, simple and user-friendly processes with which you can independently examine your product not only for physical hazards in terms of operational security, but also for weak points in information security and eliminate them.

2021/06/10 - Cybersecurity - Hans Wenner

Cybersecurity: US President Biden signs Executive Order

The U.S. President has signed an Executive Order to strengthen the cybersecurity of government entities. The implications extend beyond government entities.

Next-level security for AI-based software as medical device

To prove the safety and performance of AI-based software as a medical device, there are special documentation requirements due to data management and model development.