by Dr. Timo Weiland & Mirja Wild | Nov 27, 2024 | Advertorial, C3
The new version of the European regulatory framework for medical devices in the form of the MDR has resulted in a dynamization that affects existing medical devices as well as new products. The central elements “Clinical Evaluation Plan & Clinical...
by Henrike Stutzki | Feb 1, 2024 | Article, C3
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...
by Lea Rebholz | Feb 7, 2023 | Advertorial, C3, Interviews
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...
by Henrike Stutzki | Nov 18, 2022 | Article, C3
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...
by Henrike Stutzki | Jul 12, 2022 | Article, C3
The requirements for clinical evaluation and the significance of clinical data for medical devices have become greater as a result of the MDR – everyone knows that by now. But what does this mean for startups in the medtech sector? And what do you have to...
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