FDA Cybersecurity FAQ for Healthcare Organizations

FDA issued a direct to final guidance on Cybersecurity for devices containing off-the-shelf (OTS) software and used on intranets or the internet. It is in question and answer format and states basic FDA expectations for the device manufacturer.
The FAQ at the link provided was subsequently issued to explain the purpose of this guidance to Healthcare Organizations.

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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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