Software maintenance is the alteration and consequent distribution of software that has already been released before. Reasons for software maintenance are performance, stability and functionality improvements as well as error fixing.
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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.
- 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.
- 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.
- 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.