Welcome to QualiMEDtech

QualiMEDtech is a leading German company based in the Industrial city of Bremen. We serve Medical Device manufacturers and Importers across the globe for complying with EU regulation.

We have an extensive knowledge in EU & US FDA medical device regulations. The team of Certified Auditors and Consultants can handle any risk class of medical device for EU and USFDA.

 

European Authorized Representative Service (EAR)

We serve customers from non EU countries. Our Services are fast and economical. We also offer free sale certificate.

 

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Technical File / Design Dossier Preparation Service

Due to much imposed restrictions on Notified Body by Commission, careful prepration of the technical file is important for early certification

 

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ISO 13485:2016 / GMP Implementation Service

Medical Device CE Marking it is important to have strong implementation of Medical Device Quality Management System ( ISO 13485)

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US FDA Medical Device Registration & Listing Service

We support Medical Device Product Clearance (510k), Establishment Registration and Listing service for European Clients.

 

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