DPS
Drejtoria e Përgjithshme e Standardizimit
0 Items
My account
E-albania
Phone: +355 4 222 62 55
E-mail: info@dps.gov.al
Address: Address: "Reshit Collaku" Str., (nearby ILDKPKI, VI floor), Po.Box 98, Tiranë - Albania
Main menu

DS CEN/TR 17223:2018

Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation

Jun 20, 2019

General information

60.60     Jan 30, 2019

DPS

DPS/KT 316

Technical Report

03.100.70     11.040.01  

English  

Buying

Published

Language in which you want to receive the document.

Scope

This Technical Report provides guidance on the relationship between the requirements in the European Regulations for Medical Device and In Vitro Diagnostic Medical Devices and EN ISO 13485:2016 - Medical devices - Quality management systems - Requirements for regulatory purposes.

Life cycle

NOW

PUBLISHED
DS CEN/TR 17223:2018
60.60 Standard published
Jan 30, 2019

Related project

Adopted from CEN/TR 17223:2018