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...
Clinical evaluation as a central knowledge management process – Interview with Robert Radloff
Clinical studies – that’s what the C3 in our 4C concept stands for. Our C3 also includes the clinical evaluation, a central process for medical device manufacturers and those who want to become one. We spoke to Robert Radloff, Director of Product...
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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