by Elena Drammis | Mar 18, 2025 | Article
Diverse teams are more successful – as highlighted in McKinsey’s recent report, Diversity Matters Even More [1], which means both ethnic and gender diversity. Despite the clear advantages of diversity, women are still underrepresented in leadership positions,...
by Christian Dorn | Jan 31, 2025 | Case Study, Startups
Case Study | Projekt mit IntegraSkin Bringing an in-vitro diagnostic (IVD) to market successfully requires not only regulatory compliance, but also a business model that takes into account the particularities of the healthcare market. The startup IntegraSkin had...
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 Lea Rebholz | Oct 24, 2024 | Artikel, News
On 10 October, we welcomed over 130 guests to our annual networking event for MedTech innovation, the ‘4C Unplugged’. 37 startups from all over Germany – and with Tengable from Israel even from beyond – as well as 36 of our network partners met at the...
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 Christian Dorn | Aug 1, 2024 | Case Study, Startups
Case Study | Project with EARLAB GmbH Bringing a medical device or in-vitro diagnostic (IVD) product to market requires industry-specific expertise that startups often lack. Public funding programs such as BioMan4R2 provide founders with the necessary financial...
by Lea Rebholz | May 2, 2024 | C2, Interviews
Certification of the quality management system and obtaining the CE marking for their product are important milestones for future medical device manufacturers. The Notified Body plays a central role in this process as a testing authority. We spoke to Dietmar...
by Lea Rebholz | Mar 15, 2024 | News
A total of nine medical startups competed against each other in the “4C Check-up” online pitch contest. The aim of the five-minute pitch was to convince the expert jury of the product idea, the business model and the team. In the end, Lukas Schmelzeisen...
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 Ingo Hämmerle | Jan 9, 2024 | Case Study, Startups
Case Study | Projekt mit OSORA medical GmbH OSORA has gathered a variety of starting points for market entry in order to position the technology for bone healing simulation. Market segments exist in the areas of education and training, implant development and...
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