The link provided is an article regarding FDA’s current thinking that whole slide imaging will be treated as Class III which is a signficant barrier in terms of time and cost.
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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