TY - JOUR U1 - Zeitschriftenartikel, wissenschaftlich - begutachtet (reviewed) A1 - Limaye, Dnyanesh T1 - Development of Medical Devices JF - Current Therapeutic Research N2 - The medical devices sector helps save lives by providing innovative health care solutions regarding diagnosis, prevention, monitoring, treatment, and alleviation. Medical devices are classified into 1 of 3 categories in the order of increasing risk: Class I, Class II, and Class III.1 Medical devices are distinguished from drugs for regulatory purposes based on mechanism of action. Unlike drugs, medical devices operate via physical or mechanical means and are not dependent on metabolism to accomplish their primary intended effect. KW - clinical trials KW - EMA KW - medical devices KW - USFDA Y1 - 2016 UN - https://nbn-resolving.org/urn:nbn:de:bsz:960-opus4-9105 U6 - https://doi.org/10.25968/opus-910 DO - https://doi.org/10.25968/opus-910 VL - 78 IS - Supplement SP - S9 ER -