US ISO 13485:2016

Medical devices - Quality management systems - Requirements for regulatory purposes

UGX 50,000/=


Abstract

This Uganda Standard 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. (This standard cancels and replaces the first edition, US ISO 13485:2003, Medical devices – Quality management systems – Requirements for regulatory purposes, which has been withdrawn). This standard was published on 2022-02-04

Price UGX 50,000/=
Category CHEMICALS AND CONSUMER PRODUCTS STANDARDS
Status Voluntary
Format PDF
TC UNBS/TC 307, Medical devices and equipment.
ICS 03.100.70 Management systems 11.040.01 Medical equipment in general
Language English
Edition 2nd Edition
Sales Rating    

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