ANSI/AAMI/ISO 13485:2003
Medical devices - Quality management systems - Requirements for regulatory purposes

Standard No.

ANSI/AAMI/ISO 13485:2003

Release Date

2003

Published By

American National Standards Institute （ANSI)

Latest

ANSI/AAMI/ISO 13485:2003

Scope

Specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices that consistently meet customer requirements and regulatory requirements applicable to medical devices.

ANSI/AAMI/ISO 13485:2003 history

• 2003 ANSI/AAMI/ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes