Covering every aspect of the development of your medical devices, our team of 45 employees (technicians, engineers or PhDs) stands out for its expertise, experience and appetite for medical innovation.
Specializing in the development, manufacture and approval of medical devices under contract, Cisteo MEDICAL supports you at every stage of your project. From the first thoughts to production in a controlled atmosphere, via design verification and regulatory procedures, we bring your ideas to life in various fields such as minimally invasive surgery (implants and instrumentation), but also cardiac surgery, cardiology, spinal surgery, ENT, obesity treatment, urology, and so on.
Based in Besançon, our medical device company benefits from the experience of the microtechnology capital and the stimulating environment of the research centers in Burgundy-Franche-Comté. Cisteo MEDICAL's core business and our company's DNA, medical innovation means that we work particularly for medtech start-ups and spin-offs (90%), as well as for healthcare professionals.
With over 15 years' experience in the research and development of class III medical devices alongside start-ups, spin-offs and manufacturers, our team brings you its best technical, microtechnical and electronic solutions. Our manufacturing and assembly services for medical devices in controlled environments enable us to bring all your projects to fruition: silicone transformation, nitinol shaping, 5-axis laser welding, laser marking, heat treatment, cleaning, packaging...
In addition, our regulatory and standards support ensures the conformity of your medical devices. Approved for Research Tax Credit (CIR) and Innovation Tax Credit (CII) by the French Ministry of Higher Education and Research, Cisteo MEDICAL provides the documentation you need to build your CE marking or FDAmarki file, and helps you create and implement your ISO 13485 and/or 21 CFR part 820quality management system.
Covering every aspect of the development of your medical devices, our team of 45 employees (technicians, engineers or PhDs) stands out for its expertise, experience and appetite for medical innovation.
Your medical innovations are conceived in new, flexible premises that adapt to your needs, with a prototyping workshop, two R&D laboratories (micromechanics and electronics), two clean rooms and a workshop for assembly, mounting and electrical wiring.
For the success of your medical devices and products projects, we have a dedicated ESD area in an ISO 7 cleanroom, a 250 m² cleanroom (ISO5 and ISO7), as well as numerous mechanical and electronic CAD and ECAD/MCAD codesign software packages (SolidWorks, Altium, Solidworks Electrical Professional, Solidworks Electrical 3D).
With an international network that enables us to share cutting-edge knowledge and innovations, we work for numerous companies, start-ups and partners around the world, including France, Switzerland, Belgium, the Netherlands, the USA, Israel and Norway.
With Cisteo MEDICAL, we don't just design and manufacture your device, but also offer you comprehensive and/or targeted support, depending on your needs.
Discover our research and development services, from your idea to its realization.
We manufacture and assemble your medical devices in a controlled environment.
Our support in setting up a quality management system (QMS) in accordance with ISO 13485.
To obtain approval for your medical device, we can help you compile your technical file.
Take a look at our Qualiopi-certified training courses on medical devices (CE marking, certification, QMS, etc.).
For all your questions, our regulatory and quality hotline dedicated to medical devices.
