The U.S. President has signed an Executive Order to strengthen the cybersecurity of government entities. The implications extend beyond government entities.
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.
Is it true that an agile approach to software development for software that is a medical device cannot be used in compliance with the MDR? The answer is: “No. This is not true.”
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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 quality management system is an essential component of a medical device manufacturer. The European Medical Device Regulation (MDR) has increased the importance of quality management even further.
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.