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 | Sep 26, 2023 | Article
Questions about the 4Cs and their interrelations play a central role in the development of a plausible business model in the healthcare sector. Obviously, networked 4C knowledge is also a key advantage in fundraising. We spoke to Christian Kraft, Director M&A and...
by Lea Rebholz | Aug 10, 2023 | Article, C1
74 million people in Germany, and thus almost 90 % of the population, have statutory health insurance. So when it comes to the question of how to bring a new, innovative product to market, medtech start-ups often find a quick answer in the statutory health insurers...
by Dietmar Schaffarczyk | Jul 17, 2023 | Article, C2
As the healthcare industry continues to grow, it is essential to ensure quality and compliance with regulatory standards. Electronic Quality Management Systems (eQMS) are increasingly being used to manage and maintain quality processes in organizations. This article...
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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