2/16/99 Class II 128XP Acuson 637 units. Rev 27 software with OB calculations options are affected. Potential error condition related to OB reports printed after diagnosis. Z-787-9
2/16/99 Class II 128XP Acuson 637 units. Rev 27 software with OB calculations options are affected. Potential error condition related to OB reports printed after diagnosis. Z-787-9
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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