January 2017 Standards Landscape

This document provides a summary of primary medical device standards as well as standards specific to Medical Device and Health IT software including Cybersecurity and systems and software engineering standards. It includes an assessment of how the standards will impact the development of medical device and Health IT software. This is truly a MUST READ document for any involved in Medical Device or Health IT software and will be updated periodically and provided as part of our Standards Navigator subscriptions.

SoftwareCPRStandardsLandscapeJan2017

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Schedule Discussion with John F. Murray, Jr.

John is currently providing telephone and face-to-face meetings to discuss:  Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.

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