Medical devices and the CIR: Subcontracting eligible R&D operations

CIR and CII approved and specialized in innovative medical devices, Cisteo MEDICAL supports you from R&D to mass production of your medical device .

The Research Tax Credit (CIR), defined by the tax code, represents a 30% credit , in particular on research expenses entrusted to an organization approved by the Ministry of Higher Education and Research. It allows you to cover part of your innovation expenses .

As Cisteo MEDICAL is approved, certain services fall within the scope of expenses eligible for the CIR.

During the feasibility stages and in addition to the design stages, our Research and Development department can analyze the behavior of your innovative medical device in real conditions :

• Study of plasticity
• Modeling of mechanical effects
• Stress simulation

This step allows you to:

• Reducing risks at an early stage
• Addressing issues related to medically approved suppliers ( biocompatibility, ISO13485 )
• Identify points that will facilitate future manufacturing

We adapt our service according to the development phase and regulatory requirements and can achieve, in particular, using additive manufacturing methods:

• Modeling of functional or non-functional subassembly
• Rapid prototyping
• Very small series production possible in a controlled environment

We carry out, in-house, the mechanical design , electronic and software development of test benches in order to:

• Check performance
• Test security
• Collect data
• Verify the design : protocol, tests and test reports

Our objective as an industrialist and critical subcontractor: to design a medical device designed to be manufactured .
Before initiating the industrialization phase, going through this step allows you to:

• Consider manufacturing processes from the design stage
• Control the cost of manufacturing
• Optimize manufacturing time

Cisteo's QA/RA service can assist you in ensuring DM traceability and supporting the DHF (Device History File) design file through:

• the traceability matrix
• phase reviews
• the design review
• writing of protocols and test reports

In the case of a device under development, all of these services (including elements linked to regulatory compliance) are eligible for the CIR (Research Tax Credit) or the CII (Innovation Tax Credit).