Medical devices

Medfiles offers complete, accurate, up-to-date services in both pre- and post-market phases of the life-cycle of your medical device. Medfiles can help you get a CE marking for your product by guiding you through the appropriate conformity assessment procedure. Our experts can give you consultation or you can outsource specific assignments to us. Medfiles services cover everything from compilation of technical documentation to conduct of clinical investigations, and from establishment of quality management systems to testing of devices in our laboratory. We can handle service requests on all types of medical devices and in vitro diagnostic devices, including combination products.

We have experienced, enthusiastic and committed personnel who take pride in what they do. Our personnel undergo continuous training to ensure that you receive services of the highest quality.

Flexibility, Freshness and Fairness based on the experience and competence of our team ensure the quality of all our work. “One-stop-shop” service package is designed to encompass all your needs.

Services are always tailored on customer and product basis to precisely meet your needs.

• Device classification and selection of conformity assessment procedure
• Technical documentation / Design dossier
• Clinical evaluation
• Quality management system
• Health economics
• Laboratory services

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