ISO 14971

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 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?

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.