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ISO 13485 Certification helps organizations demonstrate that their Quality Management System (QMS) for medical devices meets the requirements of ISO 13485. The certification process addresses quality management, regulatory requirements, risk management, product realization, supplier controls, documentation, traceability, monitoring and measurement, internal audits, corrective actions, and continual improvement. It is suitable for medical device manufacturers, suppliers, distributors, and organizations involved in the medical device supply chain seeking to strengthen regulatory compliance, product quality, and customer confidence.