Solutions / Medical device testing services

Medical device testing services

Measurlabs offers a comprehensive range of accredited testing services to support medical device manufacturers throughout the full lifecycle of the device, from the R&D phase and initial regulatory submission to post-market modifications and re-evaluation.
Medical device testing
Kone logoNeste logoFermion logoPlanmeca logoSulapac logoOkmetic logo
Elina Tenhunen
Questions?

Elina Tenhunen and our other experts are happy to provide more information about our services.

One partner for all your medical device testing needs

Measurlabs’ extensive service portfolio facilitates access to practically any test required for EU MDR or US FDA submission, all through a single point of contact. We also support medical device manufacturers in the earlier stages of product development, for example, by providing screening tests to assess the cytotoxicity or sensitization potential of raw materials and intermediates.

The following is a non-exhaustive list of popular services:

  • Biocompatibility documentation (BEPs & BERs) and ISO 10993 standard tests, including toxicological risk assessments

  • Biocompatibility evaluation of breathing gas pathways

  • Reprocessing validation studies for reusable devices

  • Bioburden, sterility, and bacterial endotoxin assays

  • Wound dressing performance tests

  • Microbial barrier testing

  • Medical device shelf-life & distribution testing for packaging

A dedicated expert oversees all testing projects from method selection to final reporting. Our team’s experience with MDR and FDA requirements ensures that results are delivered in the format needed for regulatory submissions in the intended target market.

Blood pressure measurement

Biocompatibility testing

A biocompatible medical device performs its intended function without causing adverse reactions when in contact with the body. The ISO 10993 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 in accordance with the ISO 18562 standard series. Support is also available for preparing the biological evaluation plan (BEP) and the biological evaluation report (BER).

Reusable sterilized medical devices

Reprocessing validation

Reusable medical devices require validated cleaning, disinfection, and/or sterilization procedures to ensure patients are not exposed to pathogens across multiple uses. Measurlabs supports validation of both manual and automated reprocessing cycles for all device categories (non-critical, semi-critical, and critical) in accordance with the ISO 17664 standard series.

Depending on the market area, FDA or MDR guidance is taken into account when formulating the testing plan. Examples of parameters used to assess cleaning, disinfection, and sterilization efficacy include residual proteins, hemoglobin, total organic carbon, and selected microorganisms, such as E. faecium and S. aureus. In the case of chemical disinfection or sterilization, chemical residues can also be measured.

Microbiological testing

Microbiological testing

Microbiological tests are performed at different stages of the product lifecycle to ensure that medical devices are sufficiently free from microorganisms not to compromise patient safety. In addition to finished devices, testing is commonly conducted on raw materials and packaging.

Measurlabs offers 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

Sterile cotton swabs

Packaging validation

Medical device packaging must protect the device from contamination and physical damage throughout its intended shelf life and distribution chain. Measurlabs offers packaging validation services in accordance with the relevant international standards:

The testing plan is always tailored to the packaging and the enclosed device. Do not hesitate to contact our experts for more information or a quote.

Get a quote

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

Have questions or need help? Email us at or call our sales team.