AAMI Products



ANSI/AAMI/ISO 13485:2016/(R)2019 (PDF)


Member Price: $145

Non-Member Price: $258

This standard 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 requirements and regulatory requirements applicable to medical devices and related services.


Date of Publication: 17 October 2019

Pages: 50

ISBN: 978-1-57020-604-7