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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
dispositifs médicaux simulation essais

Testing and simulation

Test your medical devices in situ

Material analysis of devices

Control of the material conformity of your equipment

prothèse analyse caractérisation laboratoire

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!