Software Maintenance

Notified Bodies have published a question catalog for medical devices with AI-based software. To meet the requirements, manufacturers should complement their processes.

Medical devices that have an electrical power source must meet special safety requirements. The standard IEC 60601-1 describes these requirements and is therefore one of the most important and most extensive standards for medical devices.

Inadequate usability of medical devices can lead to misuse and thus to harm or even death of patients. This also applies to software as a medical device. For this reason, manufacturers of medical devices are obliged to carry out a development process that is linked to usability engineering.

In this article, we discuss what manufacturers must pay attention to when considering the software lifecycle and how the standards specifically help in this respect.

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