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MII x MindAhead – With confidence to the CE mark of a medical device class I

MII x MindAhead – With confidence to the CE mark of a medical device class I

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...
Planning, approval and implementation of a clinical investigation – Experiences of the startup Skinuvita

Planning, approval and implementation of a clinical investigation – Experiences of the startup Skinuvita

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...
Medical device on the rocks – The importance of design freeze for a medical device

Medical device on the rocks – The importance of design freeze for a medical device

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...
Clinical data for the clinical evaluation of a medical device – How to proceed?

Clinical data for the clinical evaluation of a medical device – How to proceed?

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...

Recent Posts

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  • MII x MindAhead – With confidence to the CE mark of a medical device class I

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      +49 1525 299 85 35

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    What awaits you

    • Experience from supporting over 120 startups
    • Experience from various coaching and consulting projects
    • Industry-specific approach “4C Business Modelling”
    • Professional specialization of the MII coaches
    • High-quality and industry-specific network

    Contact us

    … and start your individual business model development for the healthcare industry together with us!

      +49 1525 299 85 35

      Contact form

    What awaits you

    • Experience from supporting over 120 startups
    • Experience from various coaching and consulting projects
    • Industry-specific approach “4C Business Modelling”
    • Professional specialization of the MII coaches
    • High-quality and industry-specific network

    Medical Innovations Incubator GmbH

    Eisenbahnstraße 63
    72072 Tübingen, DE
    info@mi-incubator.com

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