ISO 14971

Skill packages tagged with “ISO 14971”

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ISO 14971 Risk File Author

Guided elaboration of risk management file for medical devices per ISO 14971: hazard identification, risk analysis, risk control, residual risk acceptability, and benefit–risk rationale. Flags risks above acceptability thresholds without control or justification.

    Medical Devices ISO 14971 Risk Management Compliance Benefit-Risk
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    MDevSPICE Software Risk Management Process

    Document and evidence the software risk management process per IEC 62304 and MDevSPICE: risk management plan, risk analysis, risk control, risk review, production and post-production monitoring.

      MDevSPICE Medical device IEC 62304 Risk management ISO 14971
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