FDA Slides on Effective Pre-market Meetings

The link provided is an FDA powerpoint presentation on tips for effective premarket meetings with FDA. It provides general tips applicable to all types of meetings including those involving software issues. Key items include clear agendas, specific questions, and enough detailed information so FDA can make informed responses.

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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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