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Our Integrated Service Model consist of four stand-alone services that in combination form an integrated end-to-end service for innovation and customized clients device projects that are targeting at a low-volume segment.

   

Device Strategy & Direction

Device-Strategy

Our Device Strategy & Direction is aimed at defining the optimal device route and solution given the technical, regulatory and commercial conditions for the specific intended use and therapy. In short getting the direction right first time!

   

Device Feasibility & Concept

Device -Feasibility -1

Our Device Feasibility & Concept is aimed at fast-forwarding the device strategy into design concepts and prototypes with the required level of industrial design, usability features, and architectural design in place for market testing or ‘commercial concept competition’.

   

Device Development

Device -Feasibility -1

Our Device Development is aimed at developing cost-effective and risk-controlled devices under our integrated quality management system which is certified and in compliance with relevant medical device standards. Our development process is seamlessly integrated to our Production capability for both pilot, clinical and/or low-volume production.

   

Pilot & Low-Volume Production

Pilot -&-Low -vol

Our Pilot & Low-Volume Production is aimed at delivering a production capability with high speed, high flexibility and high quality to support our innovation services for eg. devices aimed at clinical trials or low volume markets. Our production facilities are certified and in compliance with relevant medical device standards.

   


We furthermore have the regulatory competence, quality systems and market surveillance procedures in place to take on the full responsibility of being Legal Manufacturer of medical devices.

Medicom services  

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