Research & Development

For Medical devices

Thanks to its expertise in medical device research and development, Cisteo MEDICAL can support you in your projects, from idea to realization.

To ensure optimum support, we have set up a design process that enables us to integrate the expected deliverables into the technical file from the outset. As a critical subcontractor, our work is based on standards (MDR 2017/745, ISO 13485: 2016, 21 CFR Part 820, IEC 62304, NF EN 60601-1 and collateral standards), while integrating the principles of risk analysis (design for risk).

From the idea
of a medical device
to its use

A vast field of application in medical R&D

To support you from A to Z, our scope of application covers all stages of a medical device R&D project. In fact, we have extensive experience in the biomedical field, on applications such as cardiac surgery cardiology neurosurgery spinal surgery, ENT, urology, obesity treatment, cosmetic surgery, ophthalmology, etc.

We are also experts in minimally invasive surgery, thanks to our mastery of microtechniques and materials with hyper-elastic properties such as nitinol and silicones. So, whatever your field of specialization, we can find and implement the best solution for your product.

Feasibility and design
Proof of concept (POC) and prototypes
Small series for preclinical and clinical verification and validation
Mass production after industrialization

Our expertise for your medical projects

Our expertise in medical R&D

Whether you're a healthcare professional or a manufacturer, we'll put our expertise in microtechnology and electronics at your disposal to help you realize your healthcare projects.

We can provide a wide range of services from the feasibility stage through to industrialization and production start-up, including :

definition in SolidWorks CAD,
numerical simulation,
design and production of test benches,
design verification

We then carry out manufacturing and assembly in a controlled environment, right from the proof-of-concept stage.

Our expertise in micromechanics

Our expertise in micromechanics is backed up by our mastery of the ISO 13485 standard and our expertise in cutting-edge medical devices. Adapted to both minimally invasive surgery and robotics, our know-how offers significant gains in precision and comfort.

From assistance with patent registration, through 3D modeling, to the production of prototypes and test benches, we offer innovative solutions that comply with medical standards and overcome technical hurdles.

Our expertise in electronics

Cisteo MEDICAL also develops and manufactures embedded electronic systems for medical applications. We can bring your projects to life, from the design of electronic boards, sub-assemblies and complete assemblies, to the 3D CAD of mechatronic systems, including bench design and test management to validate device compliance with NF60601-1 and IEC 62304 standards.
We can also monitor your manufacturing processes in-house or externally.

Our software development expertise

Cisteo MEDICAL also provides software development to IEC 62304 (Medical Device Software - Software Life Cycle Processes).

Our team can help you with your software and embedded software development projects, whether for electromedical devices or active implantable medical devices (AIMDs).

To do this, we take charge of the design, development and validation of the software, as well as the hardware aspects of your medical device.

Our CIR approval

As a specialist in contract research and development, our company is accredited as a Research Tax Credit (CIR). Cisteo MEDICAL guarantees that all its research and development services are eligible. We can also help you apply for subsidies or repayable advances.

In the context of contract R&D, our company can support and guide you through the intellectual property process and the choice of appropriate protection, as well as assisting with the drafting of patent applications and producing the necessary drawings.