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FDA
ISO 13485: Risk Management
ISO 13485:2016 Section 5 – Management responsibility
ISO 13485:2016 Standard for Quality management systems — Requirements for regulatory purposes
ISO 13485:2016 Standard Section 4 – Quality management system
ISO 13485:2016 Standard Section 6 – Resource management
ISO 13485:2016 Standard Section 7 – Product realization
ISO 13485:2016 Standard Section 8 – Measurement, analysis and improvement
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