OTHER TESTS

At ERA Management, we offer comprehensive analyses for the specific verification and R&D needs of the medical device industry, going beyond standard methods. From shoulder prostheses to polymer aging tests and unique R&D solutions, we support you throughout all your processes with scientific and unbiased data.

Some of the other essential testing services we provide in our laboratory include:

  • Shoulder Prosthesis Static Evaluation: ASTM F1829
  • Polymer Aging Analyses: ASTM F2003
  • Customized R&D Testing Solutions: Custom Designed Fixtures
other-tests
SAMPLE STANDARD EXPLANATION
SHOULDER PROSTHESIS ASTM F1829 Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear
UHMWP – AGING ASTM F2003 Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air
CUSTOM TESTS / R&D Special Method Research and development-focused test solutions that go beyond standard methods; requiring custom design and utilizing unique fixtures and test setups.

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.

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

+90 (216) 376 66 21

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