MII x IntegraSkin – Aligning business model with regulatory requirements
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...
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...
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