Provision of objective evidence, that specified requirements have been fulfilled. The product does it right.
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- 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.
- 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.
- Technical Documentation of Medical Devices According to MDRMedical device manufacturers must provide a technical documentation for their products. The technical documentation is a compilation of all relevant documents for a product.
- Usability Engineering for Medical Devices: IEC 62366Inadequate 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.
- Software Life Cycle for Medical Devices: IEC 62304In this article, we discuss what manufacturers must pay attention to when considering the software lifecycle and how the standards specifically help in this respect.