Day

February 6, 2002
Company: Roche Diagnostics CorpDate of Enforcement Report: 2/6/02 Class: II PRODUCT All DataCare Systems Software, as follows: A) DataCare Server/Workstation Computer for DataCare ABG Data Management System for use in a blood gas point of care testing environment; Catalog GD9200. Sold in the U.S. B) DataCare Networked Client Computer for DataCare ABG Data Management System...
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IEC 62304 and other Emerging Standards Impacting Medical Device Software

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ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

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