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