GOST ISO 13485:2017
Current
Current
The latest, up-to-date edition.
Medical devices. Quality management systems. Requirements for regulatory purposes
Available format(s)
Hardcopy
Language(s)
English
Published date
30-06-2017
Publisher
Important note : All end users must be registered with an Account prior to user licenses being assigned.This standard establishes requirements for a quality management system in cases where an organization needs to demonstrate the ability to supply medical devices and provide related services that meet customer requirements and applicable regulatory requirements.
| DocumentType |
Standard
|
| Pages |
0
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| ProductNote |
This standard also identical to GOST R 54881, GOST R 58454, GOST R 59767, GOST R 59768, GOST R 59769, GOST R 59770, GOST R 59921.5, GOST R 59921.8, GOST R 70393, GOST R 70478, GOST R ISO 11737-1
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| PublisherName |
Interstandard (Russia)
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 11737-1:2018 | Identical |
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