Medical device testing services
Medical devices are subjected to strict safety and performance requirements. Third-party laboratory testing by international standards is used to demonstrate that products are compliant and can be safely brought to market.
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Biocompatibility testing is performed to ensure that medical devices do not cause adverse reactions when in contact with the human body. The ISO 10993 standard family is internationally recognized as the “gold standard” for evaluating biocompatibility, and tests performed according to it are accepted worldwide as proof of compliance.
Measurlabs offers several ISO 10993 tests, including cytotoxicity, genotoxicity, and skin sensitization testing. Preparation of the biological evaluation plan (BEP) is also available as a separate service. The tests are performed in our ISO 17025-accredited partner laboratories.
Biocompatibility tests are always tailored for the product, with more extensive testing required for more high-risk devices. When requesting a quote, please describe the product in as much detail as possible to help us provide an accurate quotation.
ISO 11737 standards are used to assess the microbiological cleanliness of medical devices, healthcare products, their components, and packaging. Measurlabs offers the following microbiological cleanliness tests, which can be ordered directly on our website:
Orders are always reviewed by our medical device testing experts before being processed to ensure that the tests are suitable for the product.
Mechanical performance and chemical safety
Medical devices and their packaging materials can be subjected to a range of mechanical tests to ensure they are durable and remain functional even after prolonged periods. Depending on the product type, necessary tests may include accelerated aging tests (HALT, HASS, etc.), fatigue testing, and evaluation of mechanical properties from tensile strength to abrasion resistance. In addition, electromagnetic compatibility (EMC) testing is needed when devices contain electronic components.
With regard to chemical characterization, it is important to ensure that medical devices do not release harmful substances to the body, especially if they are implants or other invasive devices. Testing options include chemical composition determination, contaminant screening, and analysis of ethylene oxide residuals after sterilization.
Support from medical device testing experts
When you order medical device tests from Measurlabs, one of our highly qualified testing experts will take charge of your project. Our team has experience evaluating the safety and performance of medical devices according to the EU MDR and other national and international legislation. Do not hesitate to contact us to discuss your testing needs.