Trusted Testing for Safer Medical Devices

Ensuring patient safety begins long before a medical device reaches the market. For manufacturers, the pressure to meet stringent microbiological and sterility requirements is unrelenting, as are the risks of getting it wrong. From confusion over complex ISO standards to uncertainty about when testing should begin, navigating this part of the regulatory journey is often fraught with challenges. At its core lies a critical question: can you be certain your device won’t carry a threat to the patient it’s designed to serve?

With over 6,300 m² of ISO 17025-accredited laboratory space, including six purpose-built sterility suites, Eurofins Medical Device Services answers that question with microbiological testing capabilities that are extensive, rigorous, and fully aligned with global regulatory standards.

Whether you’re validating terminal sterilisation processes, evaluating cleaning and reprocessing efficacy for reusable devices, or assessing microbial risk as part of batch release, Eurofins Medical Device Services guides manufacturers throughout the entire device lifecycle.

  • Bioburden, endotoxin, and microbial identification testing
  • Cleaning and reprocessing validation
  • Evaluation of antimicrobial device effectiveness
  • Sterility testing for batch release or sterilisation dose audits
  • Validation of terminal sterilisation
  • VDMax and other methods for establishing sterilisation thresholds
  • Water quality and cleanroom environmental monitoring

All tests are carried out using the most up-to-date standards and techniques, including ISO 11737 and USP 71. Our advanced microbial identification technology ensures precise, reliable results, helping to maximise sterilisation efficacy and minimise the risk of false negatives.

If you’re unsure of when to begin testing, or which standards apply to your device, Eurofins Medical Device Services can advise on timing, study design, and the full range of applicable testing and methodologies. Every step we take is backed by deep regulatory insight and extensive experience in microbiological control.