02631nam a22003734u 450000100220000000300060002200500170002800700150004500800410006002000300010102400310013104100080016210000370017024500790020725000060028626000160029226400160030830000120032433600260033633700260036233800360038834700210042434700080044552011160045365000430156965000430161265000570165565301840171277600360189685600640193285601020199685601420209899900170224010.1002/9781394317172Wiley20251030120306.0cr nn 008mam|a240906t2024||||xxu    fs|   |0|| 0|eng||  a9781394317172qelectronic7 a10.1002/97813943171722doi  aeng1 aMolimard, Jérôme4aut99142710aBiomedical Devices and Sensorsh[electronic resource]cJérôme Molimard  a1  bWileyc2024 1bWileyc2024  a224pp.;  atextbtxt2rdacontent  acomputerbc2rdamedia  aonline resourcebcr2rdacarrier  atext file2rdaft  bPDF  aMonitoring 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. 4aBioinstrumentation & Biosensors991428 4aSensors, Instrumentation & Measurement 4aGeneral & Introductory Biomedical Engineering99142900abiomedicine; medical devices; biomedical devices; biomedical senors; digital health science; health monitoring; body monitoring; regulation; medical ethics; medical device design08iPrinted edition:z978178630946440uhttps://doi.org/10.1002/9781394317172aWiley Online Library40uhttps://onlinelibrary.wiley.com/action/showBook?doi=10.1002%2F9781394317172aWiley Online Library423Cover Imageuhttps://onlinelibrary.wiley.com/cms/asset/18afd70b-9791-4ce2-866d-266cc959290b/9781394317172.cover.gifaWiley Online Library  c66951d66951