DANSK DS/EN ISO 13485 PDF

DANSK DS/EN ISO 13485 PDF

Name:
DANSK DS/EN ISO 13485 PDF

Published Date:
08/29/2003

Status:
[ Revised ]

Description:

Medical devices - Quality management systems - System requirements for regulatory purposes

Publisher:
Dansk Standard

Document status:
Active

Format:
Electronic (PDF)

Delivery time:
10 minutes

Delivery time (for Russian version):
200 business days

SKU:

Choose Document Language:
$33
Need Help?

This 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 requirements and regulatory requirements applicable to medical devices and related services.


Edition : 03
File Size : 1 file , 530 KB
Number of Pages : 74
Product Code(s) : DS-061, DS-061
Published : 08/29/2003

History

DANSK DS/EN ISO 13485
Published Date: 03/01/2016
Medical devices – Quality management systems – Requirements for regulatory purposes
$33
DANSK DS/EN ISO 13485
Published Date: 02/28/2012
Medical devices – Quality management systems – Requirements for regulatory purposes
$35.7
DANSK DS/EN ISO 13485
Published Date: 08/29/2003
Medical devices - Quality management systems - System requirements for regulatory purposes
$33

Related products

DANSK DS/EN 12929-2+A1
Published Date: 10/26/2022
Safety requirements for cableway installations designed to carry persons – General requirements – Part 2: Additional requirements for reversible bicable aerial ropeways without carrier truck brakes
$13.2
DANSK DS/EN 301 908-10 V4.2.2
Published Date: 11/16/2016
Electromagnetic compatibility and Radio spectrum Matters (ERM); Base Stations (BS), Repeaters and User Equipment (UE) for IMT-2000 Third-Generation cellular networks; Part 10: Harmonised Standard for IMT-2000, FDMA/TDMA (DECT) covering the essential requirements of article 3.2 of the Directive 2014/53/EU
$35.7
DANSK DS/ISO/TR 5604
Published Date: 02/12/2024
Electrochemical noise measurement for assessing the protection of metal afforded by organic coatings
$19.8

Best-Selling Products

VDI/VDE 2032
Published Date: 12/01/1975
Rolling and roller burnishing
VDI/VDE 2041
Published Date: 04/01/1991
Measurement of fluid flow with primary devices; orifice plates and nozzles for special applications
VDI/VDE 2173
Published Date: 09/01/2007
Fluidic characteristic quantities of control valves and their determination
VDI/VDE 2176
Published Date: 09/01/2007
Fluidic characteristic quantities of vanes and their determination
VDI/VDE 2177
Published Date: 07/01/1970
Description and inspection of position controllers with pneumatic gate
VDI/VDE 2178 - DRAFT
Published Date: 08/01/2008
Draft Document - Fluidic characteristic quantities of quarter turn valves and their determination