Software classified as a medical device or accessory according to the manufacturer’s intended purpose. Medical device software can be part of a medical device (embedded) or a medical device on its own (stand-alone).
Related Articles:
- Agile Development of Medical SoftwareIs 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." Find out more in our online workshop.
- 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.
- Medical apps or software: classification and approval as medical deviceSoftware like a medical app that has a medical purpose is legally a medical device. This article gives an overview of the path from a software to a medical device with CE-marking.
- Clinical Evaluation of Medical Devices according to MDRManufacturers of medical devices must carry out a clinical evaluation of their products in order to be allowed to market them in Europe. To do this, the manufacturer must use clinical data to check whether the medical device is safe and efficient.
- 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.