“International Medical Device Regulators Forum  guidance document provides concrete recommendations to all responsible stakeholders on the general principles and best practices for medical device cybersecurity (including in vitro diagnostic (IVD) medical devices). It outlines recommendations for medical device manufacturers, healthcare providers, regulators, and users to: minimize cybersecurity risks that could arise from use of the device for its intended purposes; and to ensure maintenance and continuity of device safety and performance.  This document considers cybersecurity in the context of medical devices that either contain software, including firmware and programmable logic controllers (e.g. pacemakers, infusion pumps) or exist as software only (e.g. Software as a Medical device (SaMD)).”*

Download “Principles and Practices for Medical Device Cybersecurity” PDF.


*Excerpt from http://www.imdrf.org/.

Pin It on Pinterest