FDA CDRH Software Policy Workshop

FDA’s CDRH and the National Library of Medicine held a public workshop September 3rd and 4th, 1996 as part of the process of developing a final software policy for medical devices. Summaries of the presentations and breakout sessions are available at the FDA link provided above.

SoftwareCPR Training Courses

ISO13485:2016 ISO 13485 Internal Audit(or) Training Course (Live, 3-day)

IEC 62304 and other Emerging Standards Impacting Medical Device Software (Live, 3-day)

Being Agile & Yet CompliantISO 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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