皇冠体育app

This document provides guidance for manufacturers of software as a medical device. It outlines events that may cause indirect harm and are therefore reportable. Read it in conjunction with the聽guidance on post market surveillance聽which sets out the general adverse incident reporting obligations on all manufacturers of medical devices including software as a medical device.聽

皇冠体育app aim of this guidance is to complement the requirements of聽. You should read it in conjunction with this regulation. Device-specific guidance does not replace or extend these requirements.