ISO 13485 Quality Management System

Introduction to a medical device QMS

The ISO 13485 standard is an effective solution to meet the comprehensive requirements for a QMS. Adopting ISO 13485 provides a practical foundation for manufacturers to address the regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices.

A medical device manufacturer’s quality management system is the foundation for maintaining regulatory compliance, driving improvement and effectiveness, and achieving stakeholder confidence in the manufacturer and their products.







Key resources to help your transition to ISO 13485:2016




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