For biomechanical testing required in your medical device projects, we offer a strong infrastructure through collaboration with IAF-accredited laboratories. We perform tests, particularly those required for orthopedic implants and prosthetic systems, in accordance with ISO and ASTM standards, quickly and with high accuracy.
| Test Type | Application Area |
|---|---|
| Wear Tests | Hip, knee, and shoulder replacements |
| Static & Dynamic Loading Tests | Plates, screws, nails, spinal implants |
| Torsion & Bending Tests | Joint components, prosthetic bodies |
| Fatigue Tests | Long-term durability assessment |
| Tensile and Shear Tests | Implant attachment surfaces |
| Breakpoint Tests | Defining material limits |
*All tests are conducted by an experienced technical team, based on applicable ISO/ASTM standards.
We manage the entire process from start to finish, including analysis, planning, worst-case scenario configuration, and integration of results into the technical file.
👉 Request a technical evaluation or visit our laboratory page.
We offer professional consulting services in the establishment, integration, and certification processes of international quality, environmental, and occupational health and safety management systems, primarily focusing on medical device standards (ISO 13485) and MDR processes, as well as ISO 9001, ISO 14001, and ISO 45001.
Our processes begin with a situation analysis (GAP) where we examine your company's current structure. This is followed by an end-to-end process that includes establishing a company-specific documentation structure, integrating processes, conducting internal audits, and preparing for certification audits.
The length of the process varies depending on the scope of the chosen standard, the company's existing infrastructure, the number of employees, and the complexity of the processes. Generally, the preparation and audit processes are completed within 2 to 4 months.
Yes, we are also here to support you in ensuring the continuity of the system after certification, providing internal audit support, and preparing for annual surveillance audits.
We adhere to professional confidentiality principles in all our operations. Your company's technical and commercial information is protected under mutually signed confidentiality agreements.
For details about our management systems processes and corporate consulting services, please contact us.
