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Artificial Intelligence challenges in Medical Devices
Artificial intelligence (AI) is constantly bringing improvements to the field of medical devices, with AI technology being embedded in software used
Roadmap to CE marking for medical devices and IVDs
Placing medical devices (MD) and in vitro diagnostic medical devices (IVDs) on the market is not an easy and short path. It takes years until the
Classification of software under MDR and IVDR
Software as a medical device or in-vitro diagnostic device (part I) Over the past years, software has become an essential tool in healthcare
ISO 14155 Standard vs. FDA Medical Device Regulations
Background The ISO 14155 standards were created to clarify the design, conduct, recording and reporting of clinical investigations carried out in
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