⚙️ Biomechanical Tests

Biomechanical testing is critical for verifying the durability and structural integrity of medical devices against physical stresses in clinical use. At ERA Management, we analyze the mechanical performance of orthopedic and dental implants according to international standards, providing scientific evidence that your products are sensible and effective.

Our main testing services under accreditation include:

  • Osteosynthesis and Plate-Screw Tests: Durability analysis of fixation systems.
  • Mechanical Tests of Hip Replacement: Static and dynamic behavior analysis.
  • Knee Replacement Kinematic Tests: Fatigue and wear tests.
  • Dental Implant Strength Analyses: Tests to withstand chewing forces.
  • Spinal Implant Stabilization Tests: Spinal load capacity tests.
era-lab-01-

Osteosynthesis Product Testing
OSTEOSYNTHESIS PRODUCT TESTING

 

Mechanical strength analysis of bone bonding products.


Hip Replacement Tests
HIP PROSTHESIS TESTS

 

Kinematic behavior analysis of the implant under clinical loads.


Knee Replacement Tests
KNEE PROSTHESIS TESTS

 

Fatigue, wear, and kinematic adaptation tests of knee replacement systems.


Dental Implant Tests
DENTAL IMPLANT TESTS

 

Analysis of resistance to intraoral physical conditions and chewing forces.


Spinal Implant Tests
SPINAL IMPLANT TESTS

 

Spinal load-bearing and stabilization tests of the spinal systems.


Coating Tests
COATING TESTS

 

Analysis of adhesion and abrasion resistance of implant surface coatings.


Other Tests
OTHER TESTS

 

Specific verification analyses for medical devices and medical supplies.

Frequently Asked Questions

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.

Get More Information

For details about our management systems processes and corporate consulting services, please contact us.

+90 (216) 376 66 21

Contact Form

Let's start the process together.

Information Request