06. January 2020

The European Commission published the first EU Guidance on Cybersecurity: MDCG 2019-06. This document addresses the aspects: Basic Cybersecurity Concepts Secure Design and Manufacture Documentation and Instructions for use Post-Market Surveillance and Vigilance The last chapter compares the current state of the existing guidances under the headline: Other Legislation and guidance: EU and International For the practical approach to the question what are the known hazards on cybersecurity the...

07. June 2018

With the modification FDA introduced some new standards that require some attention.