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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SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

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