Top News Q3-2021

Qualitech listed officialy on EUDAMED

Qualitech Netherlands B.V. is listed on EUDAMED as EU Authorized Representative.
             SRN: NL-AR-000002908
             link  : https://ec.europa.eu/tools/eudamed/#/screen/search-eo/bfa73493-49b6-4229-bc04-6026222bb0eb ​​

Qualitech merged with QSE SWITzerland

Qualitech is Proud to announce a long term partnership with QSE; the oldest Medical Device Service provider in Switzerland, 
            with this cooperation clients will benefit CH-REP, EU-REP, US Agent, and UK Authorized Person.
            our sister company link is http://www.qs-engineering.ch

Qualitech officially listed two customers on FDA 

Qualitech as a US Agent officially listed two of its clients on US FDA.

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Group of experts specialized in Medical Device and IVD, 25+ years' experience, Head Quarter located in UK, with affiliates in The Netherlands, USA, CANADA, Switzerland, Middle East, And North Africa region.

QUALITY BY TECHNICAL EXPERTS WITH INTERNATIONAL AVAILABILITY 

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Qualitech International

Our Staff

Human asset is the key driver of our success, since we are proud by the diversity, depth, experience of our staff. who have vast experience from the design and layout of the factories to certification, and registration of product worldwide, which will ease and expedite projects conduct, our staff has experience working in Competent Authorities, Accreditation bodies, Certification bodies, Notified bodies, technical file review for various MD code, and even standard preparation
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MDR Training 2022

$400.00 $250.00

Breakthrough Medical Device Regulation

with a clear emphasis toward [State of the Art], [Well established Technology].

The training will allow you to understand all MDR definition

The training will break through all articles without exemption.

The training will correlate MDR articles with MDCG guides, Hands-on Technical file structure, and GSPR.

The training will help you to integrate MDR Article 10 into your QMS ISO 13485

The Training will allow you to augment the role of Economic operators EOs into the current QMS.

The training will shed light on potential Major common non-conformance, and the reason for rejection of Technical files or possible delays.

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