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ISO 13485 is an international standard that sets the requirements for a Quality Management System (QMS) specifically designed for organizations involved in the design, development, production, and distribution of medical devices. Published by the International Organization for Standardization (ISO), ISO 13485 outlines a framework that ensures compliance with regulatory requirements and promotes a systematic approach to maintaining the safety and effectiveness of medical devices. This standard emphasizes risk management, traceability, and the validation of processes critical to the quality and safety of medical products. Organizations adhering to ISO 13485 demonstrate a commitment to delivering high-quality and safe medical devices, facilitating regulatory compliance, and fostering confidence among stakeholders in the healthcare industry. For Training course and Certification on MDQMS ISO 13485 Feel free to contact us on email mentioned below. email- [email protected] website- https://tnvakademi.com/ #iso #audit #tnvakademi #certification #iso13485 #qualitymanagement #medical #device #health #safetyfirst