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Medical devices
ISO 13485 is the international standard for a Quality Management System (QMS) specifically for organizations involved in the life-cycle of medical devices, including design, development, production, and servicing. It ensures consistent compliance with regulatory requirements and customer needs by establishing a framework for quality and risk management, thereby supporting patient safety and market access.
ISO 13485
Key Aspects of ISO 13485
Quality Management System (QMS):The standard provides a comprehensive framework for organizations to establish and maintain a QMS that ensures medical devices are safe and effective.Regulatory Focus:It emphasizes meeting regulatory requirements for medical devices, making it crucial for manufacturers to demonstrate a commitment to quality and patient safety.
Risk Management:The standard necessitates the integration of risk management into all QMS processes to identify, control, and monitor risks throughout the product lifecycle.
Customer Focus:It requires organizations to establish and maintain processes for communicating with customers to understand and meet their needs and expectations.
