Planning, approval and implementation of a clinical investigation – Experiences of the startup Skinuvita
In order for medical devices and IVDs to receive a CE marking, proof of their safety and performance is required. In most cases, there is not enough clinical data available for innovative products – for example from similar products – so that it is necessary to...
Medical device on the rocks – The importance of design freeze for a medical device
As an early-stage startup, you are usually in the middle of your development process in order to implement your innovative idea as a first prototype and later as the final product ready for series production. At the end of a development phase, there is a design...
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