by Henrike Stutzki | Aug 2, 2024 | Case Study, Startups
Case Study | Project with MindAhead UG The digital health startup MindAhead faced the challenge of declaring self-conformity for its risk class 1 product while meeting all regulatory requirements for safety and performance. In addition, the upcoming DiGA study also...
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 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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