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October 3, 2024
Company: Becton, Dickinson and Company, BD Bio Sciences Date of Enforcement Report: 10/03/2024 Class II PRODUCT BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FACSDuet Sample Preparation System (Base), REF: 663128, 662588, used with software V 1.4.1. Intended use: to prepare human specimens to be analyzed. Recall Number: Z-0009-2025 REASON: Sample preparation...
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Company: Becton, Dickinson and Company, BD Bio Sciences Date of Enforcement Report: 10/3/2024 Class II PRODUCT BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FACSDuet Sample Preparation System (Base), REF: 663128, 662588, used with software V 1.4.1. Intended use: to prepare human specimens to be analyzed. Recall Number: Z-0009-2025 REASON: Sample preparation...
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SoftwareCPR Training Courses:

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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