Cybersecurity is mandatory. EU Regulation 2017/745 (MDR) requires that medical devices be protected against unauthorized access. For manufacturers of medical devices and health software, this means they must actively address digital threats, both technically and from a regulatory perspective. IEC 81001-5-1 provides, for the first time, a standard for this purpose. ...
06/16/2021
References: When IEC 62304 or ISO 14971 is mentioned below, the following editions are meant: IEC 62304:2006 + A1:2015 and EN ISO 14971:2012 Problem: We are developing software/firmware that is a component of a medical device. The software (or the ...
page [tcb_pagination_current_page] of [tcb_pagination_total_pages]