GOST ISO 13485-2017

Medical devices. Quality management systems. Requirements for regulatory purposes

STANDARD published on 1.6.2018

English and Russian -
electronic design (pdf) (418.00 USD)

English and Russian -

Print design (418.00 USD)

Russian -

electronic design (pdf) (145.60 USD)

Russian -

Print design (145.60 USD)

The information about the standard:

Designation standards: GOST ISO 13485-2017
Publication date standards: 1.6.2018
The number of pages: 42
Approximate weight : 126 g (0.28 lbs)
Country: Russian technical standard
Category: Technical standards GOST

Annotation of standard text GOST ISO 13485-2017 :

Implemented changes and corrections:
Amd. 8.23