One partner. One pathway.One certified device.
From the idea to the certified device and the production site, with design, regulatory, quality and manufacturing integrated from the start.
Six capabilities. Turnkey.
Design and development
Design of medical devices of every type, from non-invasive devices to Class III implantable resorbable ones.
Research and IP
Analysis of existing patents, selection of constraint-free solutions and creation of new intellectual property.
Validation and CE marking
Device validation and the complete CE marking pathway.
International regulatory affairs
MDR, FDA, ANVISA, TGA, SFDA, KFDA. We manage the interaction with the regulatory authorities.
Technical File and quality system
Preparation of the Technical File and a quality system compliant with ISO 13485.
Production sites
Design and construction of turnkey production sites, all the way to a certified company.
Are you a medical device distributor looking to become a manufacturer?
We design your production site and support you throughout its construction.
Bare building shell.
Certified company.
Construction experience
We build production sites from scratch, from the bare building shell to a certified company.
Full technical coordination
Construction, plant engineering, utilities, HVAC, clean rooms and GMP layout under one direction.
Strategic partnerships
We work with selected suppliers and consultants to deliver reliable, scalable sites.
From distribution to manufacturing. A device of your own.
We guide you through the whole pathway: product idea, design, Technical File and CE marking, ISO 13485 quality system and a plant with clean rooms.
Higher margins
Your own product, with the value staying in your company.
Your own brand
The device carries your name on the market.
More independence
Less reliance on mandates from foreign manufacturers.
Let's talk.
Whether you start from an idea or from a product you already distribute, we build the pathway to market together.
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