Contract development, certification and manufacture of medical devices

Contract development, certification and manufacture of medical devices

Cisteo MEDICAL


Specialised in contract development and manufacture of medical devices, Cisteo MEDICAL can assist you in every stage of your projects. Whether proposing initial ideas, verifying design, assisting with regulatory requirements or carrying out controlled atmosphere production, we bring your ideas to life in a variety of fields including minimally invasive surgery (implants and instruments). Our company is based in Besançon and benefits from the experience and healthy emulation of this microtechnology capital. Whether you are a manufacturer or healthcare professional, we are here to help with all your projects.

Development


We bring you the best technical, microtechnical and electronic solutions for all your requests in medical device research and development.

Manufacturing


We offer our manufacturing and assembly of medical devices in controlled environment to carry out all your projects.

Approval


We can also create and implement an ISO 13485 and / or 21 CFR part 820 and / or RIM quality management system within your organization.

Our expertise in medical devices


With its experience in the manufacture and development of medical devices, our team of engineers has extensive expertise in fields such as the heart and cardiovascular system, spinal surgery, ENT, treatment of obesity and urology through minimally invasive (endoscopic), or other types of surgery. This means we can offer you the best technical, microtechnological and electronic solutions for all your medical device research and development needs. We also manufacture and assemble medical devices in a controlled environment to see all your projects through to completion: silicone processing, Nitinol shaping, 5-axis laser welding, laser marking, heat treatment, cleaning, packaging, and so on.

Assistance with your medical projects


Cisteo MEDICAL has research tax credit and innovation tax credit accreditation from the Ministry of Higher Education and Research and can assist you in your regulatory and normative procedures to ensure that your medical devices are compliant. We can provide the necessary advice and documentation to compile an application for CE, FDA or RIM marking, etc., for all your projects. We can also create and implement an ISO 13485 and/or 21 CFR part 820 and/or RIM quality management system at your company/organisation.

Certifications and approvals


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Authorized Tax Credit Innovation (CII)

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Chartered Research Tax Credit (CIR)

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ISO 13485:2016