We can operate over a wide area to meet all of your needs. We support you from the beginning to the end of the project, from the CAD design to the Regulatory files.
Our response involves the normative and regulatory dimensions and, of course, the human aspect inherent in working through project mode.
- CAD Design
- Regulatory strategy
- Product conformity and IMDRF technical file
- Internal / external audits
- CE marking
- Emergency missions
- Conception and development
- Regulatory and normative watch
- Validation of special processes
- Clinical evaluation
- Post market surveillance (PMS)
- Marketing optimization
- Support for international development
This list is not exhaustive. Contact us for all your needs related to medical devices or drug-device combination products, and together we will study the best strategy to implement for your developments and releases to the market.