Language:
-
- Available Formats
- Availability
- Priced From ( in USD )
-
- Immediate download
- $250.00
- Add to Cart
-
- Printed Edition
- Ships in 1-2 business days
- $250.00
- Add to Cart
Customers Who Bought This Also Bought
-
AAMI TIR102:2019
Priced From $290.00 -
Current Issues in Medical Device Quality Systems
Priced From $150.00 -
AAMI TIR 101:2021
Priced From $250.00
About This Item
Full Description
Need to stay in compliance with this standard? Purchase a checklist for guidance. (standard sold separately)
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.
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.
Document History
-
AAMI/ISO 13485:2016/(R)2019
currently
viewing
Medical devices - Quality management systems - Requirements for regulatory purposes- Most Recent
-
AAMI/ISO 13485:2003/(R)2009
Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes- Historical Version
-
AAMI/ISO 13485:1996
Quality systems - Medical devices - Particular requirements for the application of ISO 9001- Historical Version