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We create a customized roadmap for you so that you know exactly who has to do what and when. That allows you to reliably plan budgets, development, and marketing of the device, and you can be sure not to forget anything.
We leave nothing to chance. We have the experience, the templates, and the team of experts to ensure that your devices are optimally developed and pass the tests quickly and safely.
With us, you know the duration and costs from the outset. We also ensure that only the really necessary tests are carried out.
We have already completed numerous projects with various test houses. We are independent and will only recommend test houses with which we have had good experiences.
Our medical device experts know the testing requirements and associated pitfalls like the back of their hands. They are even involved in the process of writing new standards.
We support you in developing safe and effective medical devices that can be approved internationally.
Our team recommends suitable test houses and helps you to obtain and evaluate corresponding offers.
We work with you to create a test plan tailored to your device for testing and evaluating product safety. In doing so, we consider all the requirements your device must meet.
Our experts check the test results for plausibility and the reports for compliance with standards. We take over the complaints process in case of test errors or report deficiencies.
If requested, we will organize and coordinate the required tests and communicate with the test house.
Contact us and start planning the tests for your proof of safety, effectiveness, and EMC compatibility.
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+1 (240) 638 27 09
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Do you need complete and standard-compliant documentation for a review, approval, or an upcoming audit? We have the know-how and the proper templates!
Want to gain more knowledge? Our customized e-learning courses, seminars, and workshops are the key.
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