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...
by Ingo Hämmerle | Oct 27, 2023 | Case Study, Startups
Case Study | Project with Fysor GmbH An innovative product idea with a pure training approach can be launched on the market as a lifestyle product. But such a business model must also take into account the requirements and opportunities of the 4Cs in order to be...
by Ingo Hämmerle | Oct 23, 2023 | Case Study, Startups
Case Study | Project with sync2brain GmbH Medical innovations often emerge from research and are driven by a scientific perspective. However, in order for such product ideas to actually reach patients, a market-oriented view must be developed. This was the challenge...
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