How to design clinical trials for medical devices is a problem plaguing the industry today. As there are many differences in clinical trials of medical devices and drugs. This paper describes the differences of the tw...How to design clinical trials for medical devices is a problem plaguing the industry today. As there are many differences in clinical trials of medical devices and drugs. This paper describes the differences of the two points from the perspectivs of definition of medical devices and drugs, scope, phasing, subjects and design of clinical trials in details, aiming to help the related personnel make scientific decisions while conducting clinical trial design for medical devices.展开更多
This paper presents suggestions in aspects(which should meet the standards) such as alarm indication, system setup and system security during the designing process of alarm system in medical electrical equipment, whic...This paper presents suggestions in aspects(which should meet the standards) such as alarm indication, system setup and system security during the designing process of alarm system in medical electrical equipment, which can be used as a reference for manufacturers.展开更多
文摘How to design clinical trials for medical devices is a problem plaguing the industry today. As there are many differences in clinical trials of medical devices and drugs. This paper describes the differences of the two points from the perspectivs of definition of medical devices and drugs, scope, phasing, subjects and design of clinical trials in details, aiming to help the related personnel make scientific decisions while conducting clinical trial design for medical devices.
文摘This paper presents suggestions in aspects(which should meet the standards) such as alarm indication, system setup and system security during the designing process of alarm system in medical electrical equipment, which can be used as a reference for manufacturers.
