Standards are documents that describe technical requirements for products or process requirements in a formal manner with the aim of achieving high levels of safety, security, quality and compatibility.
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- NB's New Requirements for AI-based SoftwareNotified Bodies have published a question catalog for medical devices with AI-based software. To meet the requirements, manufacturers should complement their processes.
- Post market surveillance and vigilance of medical devices according to MDRManufacturers 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.
- Quality management for medical devices: ISO 13485The 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 EU Medical Device Regulation (MDR): What is changing?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.
- Electrical Safety for Active Medical Devices: The IEC 60601-1 StandardMedical 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.