Provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled. The product does the right thing.
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- Efficient market access for artificial intelligence (AI)-based software: BAIMProvided that an AI-based software has a medical intended purpose, it is subject to the regulations 2017/745 (MDR) or 2017/746 (IVDR) in the EU. To help manufacturers of AI-based software in medicine dealing with the ever-increasing stringent requirements for market access, the VDE has developed the regulatory approach “BAIM – Boost AI to Market”. In this blog post we explain the respective background.
- 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.
- 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.
- 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.