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From an auditor’s perspective: pros & cons of eQMS

From an auditor’s perspective: pros & cons of eQMS

by Dietmar Schaffarczyk | Jul 17, 2023 | Article, C2

As the healthcare industry continues to grow, it is essential to ensure quality and compliance with regulatory standards. Electronic Quality Management Systems (eQMS) are increasingly being used to manage and maintain quality processes in organizations. This article...
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...
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Recent Posts

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  • MII x IntegraSkin – Aligning business model with regulatory requirements
  • Clinical evaluation – more process than paper

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    What awaits you

    • Experience from supporting over 120 startups
    • Experience from various coaching and consulting projects
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    • 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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