From Protocol to Report, We Make Every Step Count

When it comes to testing your device’s usability, it is critical to have the right clinic or patient environment, the expertise to meet regulatory expectations, and the means to recruit participants that reflect your intended user base. And if human factors validation testing is left too late, or is poorly executed, it can derail approval altogether. Eurofins Medical Device Services network of laboratories mitigates that risk. With decades of experience, deep regulatory insight, and specialised facilities, we ensure your device is tested in the right way, by the right people, in the right setting.

Eurofins Medical Device Services supports everything from early protocol design through to submission-ready Human Factors Engineering Summary reports. Our teams draw on use-related risk analyses (URRAs) to build robust test scenarios, tailored to your device, users, and environment. We’ve planned and executed tests across a wide range of products, including auto-injectors, pre-filled syringes (PFS), ventilators, and large volume infusion pumps, and simulated use environments ranging from hospital rooms and homes to mass casualty scenes.

Whether your study needs 15 participants or 180, our experienced team recruits highly relevant user groups of physicians, surgeons, patients, caregivers, and many more. Once testing is complete, our data analysts generate clear, concise, and compliant human factors validation reports. A Human Factors Engineering Summary report will be generated for inclusion with your premarket submission. 

Products:

  • Large Volume Infusion Pumps
  • Insulin Pumps
  • Ventilators (Continuous and Noncontinuous)
  • Point-of-Care Ultrasound Imaging
  • Inhalers
  • Pre-Filled Syringes (PFS)
  • Pre-Filled Pens (PFP)
  • Auto-Injectors
  • Diagnostics and Instrumentation
  • Software
  • Ophthalmics
  • OTC consumables (test kits, contact solution, etc.)

Participants

  • Physicians
  • Surgeons
  • Pharmacists
  • Nurses
  • Paramedics/EMTs/Fire Fighters
  • Law Enforcement Officers
  • Reprocessing Technicians
  • Biomedical Engineers
  • Patients
  • Caregivers
  • Limited Literacy Adults

Test Environments

  • Home
  • Doctor's Office
  • Hospital Room
  • Operating Room
  • Intensive Care Units
  • Pharmacies
  • Mass Casualty Scenes
  • Central Reprocessing