GOST ISO 13485-2017
Medical devices. Quality management systems. Requirements for regulatory purposes

Standard No.

GOST ISO 13485-2017

Release Date

2017

Published By

RU-GOST R

Latest

GOST ISO 13485-2017

Replace

GOST ISO 13485:2011

GOST ISO 13485-2017 Referenced Document

• ISO 9000:2015 Quality management systems - Fundamentals and vocabulary

GOST ISO 13485-2017 history

• 2017 GOST ISO 13485-2017 Medical devices. Quality management systems. Requirements for regulatory purposes
• 2011 GOST ISO 13485-2011 Medical devices. Quality management systems. System requirements for regulatory purposes