SN EN ISO 13485:2016
Current
Current
The latest, up-to-date edition.
MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES (ISO 13485:2016)
Available format(s)
Hardcopy
Published date
01-03-2016
Publisher
Important note : Users cannot be edited or removed once added to your Multi user PDF.ISO 13485:2016 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 and applicable regulatory requirements.
| Committee |
INB/NK 410
|
| DevelopmentNote |
Supersedes SN EN ISO 13488. (09/2004) Supersedes SN EN 46003. (11/2007)
|
| DocumentType |
Standard
|
| Pages |
0
|
| PublisherName |
Swiss Standards
|
| Status |
Current
|
| Standards | Relationship |
| EN ISO 13485:2016 | Identical |
| BS EN ISO 13485:2016 | Identical |
| ISO 13485:2016 | Identical |
| UNI EN ISO 13485 : 2004 | Identical |
| UNE-EN ISO 13485:2016 | Identical |
| I.S. EN ISO 13485:2016 | Identical |
| NEN EN ISO 13485 : 2016 C11 2017 | Identical |
| NBN EN ISO 13485 : 2016 | Identical |
| DIN EN ISO 13485:2016-08 | Identical |
| NF EN ISO 13485 : 2016 | Identical |
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