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AAMI/ISO 13485:2016
Medical devices - Quality management systems - Requirements for regulatory purposesMore info
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.
| Author | ANSI/AAMI/ISO |
|---|---|
| Editor | AAMI |
| Document type | Standard |
| Format | File |
| Confirmation date | 2016-06-08 |
| ICS | 11.040.01 : Medical equipment in general 03.100.70 : Management systems |
| Replace | ANSI/AAMI/ISO 13485 (2003) |
| Cross references | ISO 13485 (2016-03), IDT |
| Year | 2016 |
| Document history | ANSI/AAMI/ISO 13485 (2016) |
| Country | USA |
| Keyword | ANSI 13485;13485;ANSI/AAMI/ISO 13485 (Ed.3)-2016 |