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Results for “ISO_13485”

Regulations (3)

FDA 21 CFR Part 820 Quality System RegulationQuality system requirements for medical device design, production, corrective action, records and management responsibility.FDA Quality Management System Regulation QMSRAligns FDA device quality management system requirements with ISO 13485 principles.ISO 13485

Contradictions (1)

High Production Speed vs Equipment Calibration AccuracyFoodProductionManagementTRIZ · Embed automated in-process calibration verification within the ISO 13485 production-control procedure so speed increases do not erode documented accuracy requirements.