Solutions / Medical device testing services

Medical device testing services

Regulatory frameworks such as the EU MDR and FDA guidelines require medical devices to meet strict safety and performance criteria. Measurlabs provides testing according to international standards, such as ISO 10993 and ISO 11737, to document compliance for market approval.
Medical device testing
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Biocompatibility testing

A biocompatible medical device can perform its intended function without causing adverse reactions when in contact with the body. The ISO 10993 standard series is the gold standard for assessing biocompatibility in the EU and the US, with most new devices requiring some testing according to these standards for regulatory approval.

Measurlabs offers a comprehensive range of ISO 10993 biocompatibility tests:

For devices with breathing gas pathways, we offer testing according to the ISO 18562 standard series. Support is also provided for preparing the biological evaluation plan (BEP) and the biological evaluation report (BER).

Sterility of medical devices

Microbiological testing

Microbiological tests performed according to the ISO 11737 standard series are the primary way to ensure that medical devices are sufficiently clean from microorganisms not to compromise patient safety.

Measurlabs provides microbiological testing according to the full ISO 11737 series:

  • ISO 11737-1: Bioburden determination before sterilization

  • ISO 11737-2: Sterility testing for validation of sterilization processes

  • ISO 11737-3: Bacterial endotoxin testing to evaluate pyrogenic potential

Cleaning, disinfection, and sterilization validation studies for reusable devices, as per ISO 17664, are also available.

We also offer support for selecting suitable sterilization methods, defining test parameters, and preparing documentation for regulatory submissions.

Elina Tenhunen

Questions?

Medical Device Testing Expert Elina Tenhunen is happy to provide more information about our services.

One partner for all your medical device testing needs

Measurlabs’ operating model is built on a broad network of ISO 17025-accredited and GLP-compliant partner laboratories, allowing you to obtain all required tests through a single point of contact. This ensures that results meet regulators’ expectations while removing the need to coordinate multiple suppliers.

The following are some examples of our service scope beyond ISO 10993 and ISO 11737 tests:

  • Wound dressing performance tests (EN 13726)

  • Microbial ranking of packaging materials (ASTM F1608)

  • Accelerated aging of sterile barrier systems (ASTM F1980)

  • Shipping container and packaging system evaluation (ASTM D4169)

  • Electromagnetic compatibility testing (IEC 60601-1)

When you work with Measurlabs, a dedicated expert oversees your projects from test selection to final reporting. Our team’s experience with EU MDR and FDA requirements ensures that results are delivered in the format needed for regulatory submissions in your target market.

For a practical example of the benefits of partnering with us, see this case study on how we streamlined Intelinked's MDR submission process.

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