Assessment Medical Devices
DARE!! Consultancy has performed a medical assessment on a heated breathing tubing system according to the medical device directive for Plastiflex Healthcare located in Paal-Beringen, Belgium. At first glance a simple product, but the product must be in strict compliance requirements for medical devices.
Hybernite Connector of Plastiflex Healthcare
The combination of bio compatibility and the application of electric heated wires into a tubing system made this project very challenging. Plastiflex Healthcare has managed to develop a great product which passed all tests and investigations at DARE!! Consultancy. The resulting report played a significant role in the technical file that was presented to and accepted by both the American Food and Drug Administration (FDA) and SGS in Europe. A great accomplishment for Plastiflex Healthcare as well as for DARE!! Consultancy.
Experience of the customer
“The Hybernite Rainout Control System is a heated breathing tubing system that is intended for use in sleep apnea therapy and non-invasive ventilation.. For Plastiflex Healthcare, the Hybernite is the first step in the world of medical devices. In our quest for a test-house for EN60601 and EMC testing, we met with D.A.R.E!! Consultancy. We were mostly impressed by the expertise and willingness of D.A.R.E!! to understand and convert each aspect of our new device into the test setup. Due to the short lead time and timely delivery of the test reports, we were able to make our milestones. We are confident this first project is a great basis for future cooperation and partnership with D.A.R.E!! for testing and evaluating our new medical devices.”
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