Guidance document : pre-market requirements for medical device cybersecurity. : H164-278/2019E-PDF

"Health Canada considers the inclusion of cybersecurity risk control measures an important consideration in issuing medical device licenses. Therefore, this guidance document provides medical device manufacturers advice on the practices, responses and mitigation measures that can improve the cybersecurity of their device. This guidance also outlines the information to be submitted as part of a medical device licence or licence amendment application to demonstrate that a medical device, consisting of or containing software, is sufficiently secure from threats that may exploit a vulnerability within a medical device possibly causing harm"--Policy objectives, pages 5-6.

Lien permanent pour cette publication :
publications.gc.ca/pub?id=9.873919&sl=1

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