The laboratory is specially equipped to evaluate medical and IVD medical devices. There, you can simulate clinical and domestic scenarios. That allows you to meet legal requirements and identify specific use problems. The special equipment ensures a quick and convenient start to the study.
In the laboratory, you will find modern and professional equipment. An observation room with a one-way mirror allows anonymous observations on site. Video technology provides a safety record of the output. With live streaming, your colleagues can follow the study worldwide and track use problems.
Our US laboratory in Arlington, Virginia, benefits from its close proximity to Washingon, D.C. as well as its excellent public infrastructure of its surroundings, easy to reach by public transportation. If you prefer to drive, ample parking is available on-site
Thus, the lab's accessibility facilitates the recruitment of test subjects, including those from surrounding health institutions.
A loading ramp in the courtyard makes it easy to deliver bulky devices. You can temporarily store materials before and after the study. A catering service saves you the trouble of organizing catering so you can concentrate fully on your study. If you need translators, we can help you with that, too.
We find the right participants for you – from aging patients to cardiac surgeons. We receive and guide the test subjects and minimize "no-shows" so you can conduct the study as planned. We even take care of the compensation of the test subjects with our legal subtleties.
If you need spontaneous support, such as when adapting the plan or conducting your usability study, our usability experts will be happy to help. You can count on their expertise and experience to conduct your study quickly, effectively, and in compliance with the law.
Phone
+1 (240) 638 27 09
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We help you accelerate the development and approval of your devices through our formative evaluations.
We help you create the prerequisites for the rapid approval of your devices with IEC 62366-1 and FDA compliant summative evaluations.
We take over the complete recruitment of healthcare professionals for your usability studies – from search to support on the day of the test.
We support you in proving your marketing claims quickly and credibly, thereby advancing the marketing of your products.
Need a standard-compliant usability file (human factors engineering file) to pass audits and approvals? We have the know-how! Our customized templates and professional support make it possible.
We analyse and evaluate the usability of your medical devices in everyday use in accordance with MDR after they have been placed on the market.
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