Solutions / Medical device testing services

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 assessment

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 and GLP-certified partner laboratories.

Biocompatibility tests are always tailored for the product, with more extensive testing required for more high-risk devices. In the case of low-risk devices, it may be possible to perform all tests with in vitro methods (without animal testing). When requesting a quote, please describe the product in as much detail as possible to help us provide an accurate quotation.

Sterility of medical devices

Microbiological quality

ISO 11737 standards are used to assess the microbiological cleanliness of medical devices, healthcare products, their components, and packaging. The following microbiological tests 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. You can also always contact us through the form at the bottom of this page to discuss testing options.

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, fatigue testing, and evaluation of mechanical properties from tensile strength to abrasion resistance.

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.

Heini Virtanen

Questions?

Medical device testing expert Heini Virtanen is happy to help.

+358 40 179 5383

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, FDA guidelines, and ISO standards. Do not hesitate to contact us to discuss your testing needs.

Get a quote

Fill in the form, and we'll reply in one business day.

Answering the following questions helps us prepare an offer faster:

  • What is the medical device's intended use, body contact site, and contact duration?

  • Have you already determined, which tests should be conducted on the device?

  • Do you need the tests for R&D purposes or for submission to officials?

Have questions or need help? Email us at or call +358 50 336 6128.