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 guidance on this. ...
01/29/2019
SW metrics from a QMS perspective Why should software quality metrics be used in the product lifecycle? A software metric maps a software unit into a numerical value. The numerical value represents a measure of the internal quality of software. Software code metrics are ...
10/02/2017
ISO 13485:2016 requires a risk-based assessment of your processes in the quality management system (QMS). Many companies ask themselves whether only production processes should be considered, or whether all processes should be considered. Furthermore, the question often arises, ...
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