🧪 Testing Services

Medical device manufacturers undergo the necessary testing according to EU product legislation in laboratories partnered with ERA. The main testing services offered by ERA include:;

  • Biomechanical tests (static strength, compression-tension, fatigue, torsion, and wear) of orthopedic implants.
  • Biocompatibility tests (in-vitro cytotoxicity, genotoxicity, blood compatibility, irritation, sensitization, acute systemic toxicity, subchronic toxicity tests according to ISO 10993 series standards)
  • Validation tests (ISO 11607-2 packaging validation, ISO 14644 series cleanroom validation, etc.)
  • Biological tests and bench tests (ISO 11737-x bioburden and sterility tests, performance tests according to medical device standards)
  • Electrical safety and electromagnetic compatibility tests for active medical devices (EN 60601-1 and EN 61010-1 general electrical safety tests, EN 60601-1-2 and EN 61326 electromagnetic compatibility, EN 60601-2 series special medical device safety tests, etc.)
Biomechanical Tests
BIOMECHANICAL TESTS

Mechanical strength, fatigue, and performance analyses of medical devices and implants under static and dynamic loads.

Biocompatibility Tests
BIOCOMPATIBILITY TESTS

Comprehensive analyses verifying biological safety within the framework of ISO 10993 standards.

Microbiological Tests
MICROBIOLOGICAL TESTS

Reliable analyses that provide sterilization effectiveness, bioburden, and contamination control for medical devices.

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

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