ISO 13485 MEDICAL DEVICE QUALITY MANAGEMENT POLICY

The ISO 13485 Policy defines the organization’s dedication to meeting regulatory requirements and maintaining the highest standards in the design, production, and servicing of medical devices. Aligned with ISO 13485:2016, this policy emphasizes risk-based thinking, product conformity, patient safety, and continual improvement of the Quality Management System. It serves as a guiding framework for achieving regulatory compliance, enhancing product reliability, and ensuring customer and stakeholder satisfaction in the medical device industry.

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