IVDR – Regulation (EU) 2017/746
CE marking represents confirmation of a medical device manufacturer’s claim that a device meets the General Safety and Performance Requirements (GSPRs) of the In Vitro Diagnostics Regulations RE(EU) 2017/746. QMD Services offers conformity assessment activities necessary to comply with this regulation. Our review processes allows you to build reliability and confidence into your CE marking project.
QMD Services offers conformity assessment activities as published in NANDO under Notified Body (NB) number 2962. Applications for conformity assessment activites acc. to Regulation (EU) 2017/746 on in vitro diagnostic medical devices are accepted in German or English language.
HOW TO APPLY FOR CERTIFICATION
Please get in contact with us via our Online Contact Form. Following an initial discussion with our Customer Service Team, you will need to submit us relevant information about your company and products.
Good To Know
QMD Services GmbH
Headquarters
Zelinkagasse 10/3
1010 Vienna, Austria
Tel.: +43 1 533 0077
Operations Office
Am Winterhafen 1
4020 Linz, Austria
Phone
+43 1 5330077
office(at)qmdservices.com
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