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February 9, 2015
FDA issued a revision to its “Mobile Medical Applications” Guidance Feb 9, 2015. The revision was to make this guidance consistent with the final “Medical Image Storage Devices, and Medical Image Communications Devices” guidance. Specific changes are FDA’s exercising of enforcement discretion to exempt MDDS and some Mobile Medical Apps from compliance the FDA regualtion....
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SoftwareCPR Training Courses

IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software

ISO 14971 Risk Management (typically with heavy emphasis on software aspect)

IEC 81001-5-1 Cybersecurity Lifecycle

ISO 13485 QMS Requirements & optionally ISO 19011 for leading audits

Being Agile Yet Compliant (AAMI TIR 45)

IEC 29119-1 Software and System Testing

US Classification for Software Devices

IEC 62366 Usability Process and Documentation

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

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