02673nam a22003854u 4500 10.1002/9781394317172 Wiley 20251030120306.0 cr nn 008mam|a 240906t2024||||xxu fs| |0|| 0|eng|| 9781394317172 electronic 10.1002/9781394317172 doi eng Molimard, Jérôme aut 91427 Biomedical Devices and Sensors [electronic resource] Jérôme Molimard 1 Wiley 2024 Wiley 2024 224pp.; text txt rdacontent computer c rdamedia online resource cr rdacarrier text file rdaft PDF Monitoring the human body is a key element of digital health science. Low-cost sensors derived from smartphones or smartwatches may give the impression that sensors are readily available; however, to date, very few of them are actually medical devices. Designing medical devices requires us to undertake a specific approach demanding special skills, as it concerns the integrity of the human body. The process is tightly framed by state regulations in order to ensure compliance with quality assessment, risk management and medical ethics requirements. This book aims to give biomedical students an overview on medical devices design. It firstly gives a historical and economical approach, then develops key elements in medical device design with reference to EU and US regulations, and finally describes sensors for the human body. The clinical approach is presented as the central element in medical device qualification and this offers a perspective on the use of numerical simulation, particularly since its continued growth in the USA; despite the fact that the approach is strictly limited by regulations. Bioinstrumentation & Biosensors 91428 Sensors, Instrumentation & Measurement General & Introductory Biomedical Engineering 91429 biomedicine; medical devices; biomedical devices; biomedical senors; digital health science; health monitoring; body monitoring; regulation; medical ethics; medical device design Printed edition: 9781786309464 https://doi.org/10.1002/9781394317172 Wiley Online Library https://onlinelibrary.wiley.com/action/showBook?doi=10.1002%2F9781394317172 Wiley Online Library Cover Image https://onlinelibrary.wiley.com/cms/asset/18afd70b-9791-4ce2-866d-266cc959290b/9781394317172.cover.gif Wiley Online Library 66951 66951