• Auxergo

Software as a Medical Device Webinar

In the middle of November, Auxergo joined a webinar on human factors considerations of software as a medical device (SaMD). SaMD is defined by International Medical Device Regulators Forum (IMDRF) as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device”. SaMD should be considered during the design and development process, as well as comply with relevant human factors regulations. These regulations are consistent with human factors regulations for medical devices, especially for the case of clinical evaluation and use-related risk assessment and control. Human factors processes for SaMD should be applied with the same rigour as for medical devices in general.

47 次瀏覽0 則留言

奥德馨亿(Auxergo)是Auxergo Ltd的注册商标 ©Auxergo2021。奥德馨亿保留所有权利。


法律与隐私保护政策 | 商业资源


英国剑桥 | 中国上海

  • LinkedIn - White Circle
  • Facebook - White Circle
  • Twitter - White Circle
  • Instagram