Picture
QUALITECH INTERNATIONAL
  • Home
  • Services
    • Regulatory Affairs >
      • Classification
      • Registration
    • Training
    • Clinical Evaluation >
      • Clinical Evaluation
    • Translation
    • Technical file review
    • EUAR
    • FDA Services
    • Calibration
  • Contact

News

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 new customers on FDA 
Qualitech as a US Agent officially listed 10 clients on US FDA.

Who we are?

a Group of experts specialized in Medical Device and IVD, 25+ years' experience, Head Quarter located in Netherlands, with affiliates in The [UK, USA, CANADA, Switzerland, United Arab Emarates, And North Africa region].

QUALITY BY TECHNICAL EXPERTS WITH INTERNATIONAL AVAILABILITY 
=
Qualitech International
Our Head Quarter

We offer you Years of Experience

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
​

Services

Clinical Evaluation
Clinical Evaluation
Professional Translation
Professional Training
Regulatory Affairs Corners
World wide Registration
Compliance Corner
Technical File review Corner
FDA Services Corner
EU Authorized Rep.

Services

EUAR
Translation
Literature
​Technical Files

FDA Preparation

Company

About
Policy

Support

​Contact
Imprint
Privacy Policy
Terms of Use
Picture
Qualitech International
​© COPYRIGHT 2015. ALL RIGHTS RESERVED.
  • Home
  • Services
    • Regulatory Affairs >
      • Classification
      • Registration
    • Training
    • Clinical Evaluation >
      • Clinical Evaluation
    • Translation
    • Technical file review
    • EUAR
    • FDA Services
    • Calibration
  • Contact