MII x MindAhead – With confidence to the CE mark of a medical device class I
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...
MII x EARLAB – From a research team to an audit-ready QMS
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...
MII x OSORA – Faster go-to-market and why the medical device is now at the end of the roadmap
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...
MII x Fysor – How an idea became the product “Apelvo”
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...
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