Medical devices From design to compliance of your medical devices
The development of medical devices requires strict control over industrialization processes and compliance with regulatory standards.
Our services include:
- Design and prototyping: technical studies, additive manufacturing, material optimization.
- Engineering in the project phase: procurement, construction management, stakeholder coordination.
- Validation and qualification: biocompatibility testing, functional verification, compliance with ISO 13485 standards.
- Production and market launch: support for manufacturing processes and management of CE/FDA certification.
Case study SERF à Décines
We carried out the design study and project management for a new cleaning unit and an ISO 7 clean room for primary and secondary packaging of medical implants (hip prosthesis).
Comprehensive support to ensure safety and performance
In a rapidly expanding medical devices market subject to stringent regulations, our multidisciplinary expertise is essential to speeding up the development and compliance of your innovations.
We offer comprehensive support covering the entire product life cycle, from design to marketing. Our team masters the specificities of each class of medical device, from Class I products to active implantable devices and in vitro diagnostics.
This expertise enables us to adapt our approach to each project, guaranteeing patient safety and device performance.
As your trusted partner, we guide you through the regulatory complexities, optimising your development processes to bring to market innovative, safe and high-performing medical devices that meet the evolving needs of the healthcare sector.
To support our ambition and drive innovation, we focus on integrating dynamic and skilled talents.