FDA Adopts ISO 13485 with QMSR Final Rule

FDA Adopts ISO 13485 with QMSR Final Rule     The FDA has issued the Quality Management System Regulation (QMSR) Final Rule. The QMSR rule emphasizes risk management activities and risk-based decision making and aims to reduce regulatory burdens on device manufacturers and importers by harmonizing domestic and international requirements, specifically through the adoption of ISO …

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