Medical device : analysis, testing and simulation
The 6NAPSE Group verifies the conformity of medical devices by analyzing materials. We also perform product qualification with our dual skills in testing and digital simulation.
Expertise for the medical industry
The medical industry must guarantee the reliability of its medical equipment and devices. To allow the placing on the market or the optimization of its devices, it is therefore essential to validate their characteristics or their behavior in the environment of use.
From tests, through the simulation and characterization of materials in the laboratory, the 6NAPSE Group provides its expertise for all devices used in the medical world: orthopedic insoles, glasses, prostheses, catheters, artificial hearts, devices, etc.
Standards
- ISO 13485: quality management of medical devices
- ISO 19227: cleanliness of orthopedic implants
- ISO 10993-12 and -18: biological evaluation
Testing and simulation
Test your medical devices in situ
- Environmental tests – aging under controlled atmosphere
- Simulation
- Support for the design and development of prototypes
- Simulation of patient comfort: calculation of operating noise (hearing discomfort for the patient), calculation of thermal comfort, vibration comfort
- Mechanical resistance and fatigue of the equipment
- EMC calculation
- Engineering
- Power electronics design : power supply for medical devices, pulsed power supply, battery chargers
- Acoustic measurement and testing of devices
- Vibration measurement and testing of devices
Material analysis of devices
Control of the material conformity of your equipment
- Physico-chemical characterization of materials
- Polymers (silicones, resins, elastomers, etc.)
- Metals and metal alloys, determination of grades (eg: titanium)
- Ceramics and dental cements
- Powders analysis for additive manufacturing
- Chemical analyzes to validate the chemical cleanliness of the parts before use
- Identification of surface contamination, search for heavy metals ICH-Q3D, analysis of foreign bodies
- Failure expertise: corrosion, rupture and crack
- R&D support for new products or product optimization
Application cases
- Polymer analysis of an artificial heart and mechanical tests
- Endurance and bending tests of orthopedic insoles
- Appearance and surface inspection of catheters during aging tests
- Dosage of heavy metals in extractables from medical devices
- Validation of the robustness of medical equipment (screens, hose connectors)
- Simulation of patient exposure to electromagnetic waves
- Acoustic tests for checking the conformity of the results of an audiometry system
- Design of power supplies and power generators for imaging
6NAPSE Group assets:
- Reactivity: emergency 1-3 days
- Experience of more than 30 years
- Quality commitment: CIR and CII, ISO 9001
- According to customer standards and specifications
Contact us to discuss your needs quickly and technically!