Change the classification of several types of devices, specifically increasing the class of certain software as a medical device and aligning IVD classifications with those of the International Medical Device Regulators Forum.加强对质量管理体系和技术文件的要求。Strengthen the requirements for quality managem...
It covers stand-alone software (also known as software as a medical device) but not software that is part of an existing medical device because this seen to be part of the device, eg software that controls a CT scanner. Key points and existing guidance Stand-alone software Software which ...
The United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) has updated its guidance on determining whether an app is classified as a medical device. The new guidance features revised flowcharts to help software develop...
Change the classification of several types of devices, specifically increasing the class of certain software as a medical device and aligning IVD classifications with those of the International Medical Device Regulators Forum. 加强对质量管理体系和技术文件的要求。 Strengthen the requirements for quality man...
1. What is medical device ? Any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the sp...
Paul Dixey and Sam Walmsley offer some points to consider when developing an app. The Mersey Burns app has just been launched on the iTunes Store and this is the first in the UK to be registered with the MHRA as a Class I medical device ...
1. What is medical device ? Any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the sp...
1. What is medical device ? Any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the sp...