SoftwareCPR Partial 820.70(i) Training Manual$

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The pdf at the link provided contains a set of FDA reference documents and partial examples used in SoftwareCPR training courses on Validation of Production and Quality System Software and Part 11. This is just a partial set and other examples and checklists are tailored for each course offering.

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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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