Software Life Cycle

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

Manufacturers of medical devices must monitor their products on the market. The European Medical Device Regulation requires manufacturers to systematically and actively collect information on product use after it has been placed on the European market.

The European Medical Device Regulation (MDR) replaces the Medical Device Directive (MDD) and the Directive on Active Implantable Medical Devices (AIMDD). This article provides an overview of the major changes and the current status of implementation.

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.

Medical device manufacturers must provide a technical documentation for their products. The technical documentation is a compilation of all relevant documents for a product.