With over 15 years of experience in the research and development of Class III medical devices alongside startups, spin-offs, and manufacturers, our team provides you with the best technical, micro-engineering, and electronic solutions. Our manufacturing and assembly services for medical devices in a controlled environment enable us to successfully complete all your projects: silicone processing, nitinol forming, 5-axis laser welding, laser marking, heat treatment, cleaning, packaging, and more.
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.