BS EN 13485

What is  BS EN ISO13485 ?

BS EN ISO13485 is intended for companies that design, develop, produce, install or service medical devices.

BS EN ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements.

The primary objective is to facilitate harmonized medical device regulatory requirements for quality management systems.

BS EN ISO 13485 can also be used by internal and external parties, including certification bodies, to assess the organization’s ability to meet customer and regulatory requirements.