Day

June 16, 2005
This content is only available to Premium Level and higher subscribers.  See our Subscribe page for information on subscriptions. At a 1-day current regulatory topics session by ASQ held in Needham, MA, on June 16, 2005, Alan Kusinitz, Managing Partner of SoftwareCPR®, gave a presentation on the recent FDA Cybersecurity Guidance and the new revised FDA "Guidance...
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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

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