ISO 13485
The Quality Management System (QMS) under ISO 13485 is a globally recognized framework tailored for medical device manufacturers and suppliers. It provides guidelines for establishing and maintaining a comprehensive system that ensures the safety, effectiveness, and regulatory compliance of medical devices.
ISO 13485 covers key areas such as quality policy, documentation, risk management, design and development, supplier management, production control, sterilization, packaging, monitoring, corrective actions, and post-market surveillance. By adhering to this standard, organizations demonstrate their commitment to producing high-quality devices that meet regulatory requirements and fulfill user needs.
A robust QMS under ISO 13485 fosters consistency, efficiency, and continual improvement throughout a device's lifecycle. It enhances patient safety, builds confidence among healthcare professionals, and supports adherence to global regulatory standards.
In essence, ISO 13485's QMS is a proven approach that ensures the quality and reliability of medical devices, contributing to the well-being of patients and the integrity of the medical device industry.
We provide technical support to assist in the establishment of Quality Management System for compliance with ISO 13485.
Contact us today, and let's embark on this journey together.
Experience the confidence that comes with working with a proven leader in medical device registration.