We offer chemical characterization and toxicological risk assessment analyses to verify the material safety of medical devices.
Some of the other essential testing services we provide in our laboratory include:
| SAMPLE / SCOPE | STANDARD / METHOD | EXPLANATION |
|---|---|---|
| TOXICOLOGICAL RISK ASSESSMENT | ISO 10993-17 | Biological Assessment of Medical Devices - Part 17: Toxicological Risk Assessment of Medical Device Components (prepared by ERT-approved experts) |
| CHEMICAL CHARACTERIZATION | ISO 10993-18 | Biological Evaluation of Medical Devices - Part 18: Chemical Characterization of Medical Device Materials within the Scope of Risk Management Process |
| CHEMICAL ANALYSES | GC-MS, LC-MS, ICP-MS, etc. | GC-MS, GC-MS MS, LC-MS, LC-MS MS, HPLC, ICP-MS, FT-IR, XRF, Titrimetric analyses, Differential Scanning Calorimetry (DSC) (-90/+550℃), Composition Analysis by Thermogravimetry (using TGA). |
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.
