FDA new device guidance planned for 2008.

The full list of planned guidances are at the link provided. Some of proposed general guidances that may be relevant to software include:-Computer-assisted Detection Devices for Radiological Images and Data
-Electronic Copies and Electronic Submissions of Data
-Risk Management Information in Premarket Submissions
-60601-Third Edition in submissions

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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