What is ISO 13485?

ISO 13485 is an international standard that specifies requirements for a quality management system (QMS) for organizations involved in the design, production, installation, and servicing of medical devices and related services. The standard aims to ensure that medical devices consistently meet customer and regulatory requirements. Key aspects of ISO 13485 include:

1. Quality Management System Requirements: Establishing and maintaining a QMS that ensures product quality and regulatory compliance.
2. Management Responsibility: Commitment from top management to implement and maintain the QMS, including defining quality policies and objectives.
3. Resource Management: Ensuring that sufficient resources (human, infrastructure, and work environment) are available to implement and maintain the QMS.
4. Product Realization: Procedures for the design and development of medical devices, ensuring that products meet customer and regulatory requirements.
5. Measurement, Analysis, and Improvement: Monitoring, measuring, and analyzing processes to ensure the effectiveness of the QMS and implementing continuous improvement.

ISO 13485 focuses on risk management and design control throughout the product lifecycle, emphasizing the safety and effectiveness of medical devices. It is harmonized with regulatory requirements in many countries, making it a critical standard for medical device manufacturers aiming to access global markets.