Custom medical device manufacturing in France
The AXE Group specializes in the design and custom manufacture of medical devices in France. With recognized expertise in sheet metal work,
National and European presence
We operate throughout France and internationally, with production sites in :
- Lisieux (Normandy)
- Romorantin (Loir-et-Cher)
- Oradéa (Romania)
- Wu Jiang (China)
This multi-site presence enables us to stay as close as possible to major healthcare centers, and to ensure optimized logistics on a European scale.
An industrial partner committed to health
AXE supports medical device manufacturers throughout their projects: from the design phase, through prototyping, manufacturing and compliance testing, to final delivery.
Our teams work in a controlled, certified environment, with integrated production workshops, business experts and rigorous quality processes. The result: customized, reliable, traceable and industrialized solutions.
An integrated production chain from A to Z.
Our industrial organization is based on a complete, internally integrated value chain, with flexible production capacity adapted to the requirements of the medical sector. Our main areas of expertise:
- Functional study and 3D modeling
- Choice of biocompatible materials (316L stainless steel, anodized aluminum, PEEK, PTFE, etc.)
- In-house rapid prototyping
- Fine sheet metal work and 3- to 5-axis CNC precision machining
- Assembly, mechanical testing and quality control
- CE/MDR*-compliant packaging, labelling and documentation
Complementary services for the medical industry
In addition to manufacturing, we offer high value-added services:
- Feasibility studies
- Design-to-cost analyses to optimize your technical and budgetary choices
- Assistance in compiling the CE/MDR* technical file (traceability of materials, validation reports, quality documentation)
- Storage of critical components and logistics for small production runs
We make a point of facilitating regulatory compliance while reducing time-to-market.
Case studies: radiology and medical imaging
Customer: European leader in mammography
This customer entrusted us with the manufacture of mechatronic sub-assemblies for radiology equipment. We outsourced the supply chain to qualified suppliers:
- Wiring
- Electronic sub-assemblies
- Complex 3/5-axis machined parts
- Final integration according to quality requirements
A mechatronics design office dedicated to the medical sector
Our design office is staffed by engineers specializing in medical instrumentation, who are involved from the R&D phase onwards, to ensure that design complies with ISO 13485 and IEC 60601 standards.
Our services
- Risk analysis and standard requirements
- Design or co-design with your technical teams
- Concept validation via functional prototypes
- Preparing the technical file for CE marking
Our production resources: high precision and traceability
Our production equipment is specifically adapted to the requirements of the medical sector:
- 3- to 5-axis CNC machining centers for custom parts
- CNC press brakes for fine sheet metal work
- High-precision laser cutting
- Prototyping and assembly workshop
- Metrological control stations (certified reports)
- Batch traceability, documentation and archiving
Compliance and quality assurance
Our ISO 13485 certification guarantees :
- Compliance with CE/MDR* standards
- Production traceability
- Responding to quality audits and specifications
We can help you secure your projects and pass your regulatory audits.
*CE: mandatory certification for the marketing of medical devices in the European Union.
*MDR: Medical Device Regulation is the European regulation (EU) 2017/745, which comes into force in May 2021, and governs the manufacture, marketing and monitoring of medical devices in Europe.
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Frequently asked questions – Sheet metal and custom medical machining
Why put your trust in the AXE Group?
- Recognized industrial expertise in the medical devices sector;
- Made 100% in France;
- Ability to produce small batches or pre-production runs;
- Reactivity, industrial flexibility and accelerated prototyping;
- Strong references in medical imaging, robotics and laboratories.
What materials do you use?
Medical stainless steel, anodized aluminum, POM, PEEK, PTFE, etc.
Do you produce in small batches?
Yes, we produce prototypes, pre-series and series from 1 to 500 parts.
Are you involved right from the design stage?
Yes, our medical engineering department will work with you right from the drawing up of specifications.
Do you support your customers in CE/MDR* compliance?
Yes, our quality team at can help you draw up technical files, trace materials and regulatory documentation.
