12/10/98 Datalink Management System Software Versions 4.1-4.2 Beckman Coulter 248 units. The devices may allow the test results from an associated clinical instrument to be placed under an incorrect sample ID. Z-829-9
12/10/98 Datalink Management System Software Versions 4.1-4.2 Beckman Coulter 248 units. The devices may allow the test results from an associated clinical instrument to be placed under an incorrect sample ID. Z-829-9
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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