We leave nothing to chance. We have the experience, the templates, the databases, and the expert team to get your devices through the approval process quickly and safely.
With us, you know the duration and costs from the outset. And we only test what really needs to be tested using a risk-based approach.
We have already completed numerous projects with our partner laboratories. Therefore, you can be sure that your biocompatibility tests will run without any problems.
We are committed to demonstrating the biological safety of your medical device without animal testing wherever possible and, instead, carrying out the material characterization approach, including chemical analysis.
Our medical device experts know the necessary tests and potential pitfalls like the back of their hands. They even organize interlaboratory comparisons to improve data quality.
We ensure that your medical devices are not only biologically safe but also successful in the market.
Upon request, we will take over the entire organization, coordinate the necessary tests, and communicate with the laboratory.
We work with you to create a customized strategy for the testing and evaluation of biocompatibility. That is the basis for organizing laboratory tests and creating the biological evaluation plan (BEP).
Our experts check the laboratory results for plausibility and the reports for compliance with standards. We take over the complaints process in case of laboratory errors or reporting deficiencies.
Our team selects the most suitable testing laboratory for your device from our partner laboratories. To do this, we define the specific test parameters in advance and choose appropriate test methods.
Contact us to find the best testing strategy for demonstrating biocompatibility.
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+1 (240) 638 27 09
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We help you create a complete and legally compliant biocompatibility file for approval or an upcoming audit.
Our experts help you reprocess your medical devices in compliance with the law – quickly and safely validated.
Want to gain more knowledge? Our customized e-learning courses, seminars, and workshops are the key.
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