Medical Innovations Incubator GmbH - Tübingen
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The role of the Notified Body – An interview with an auditor

The role of the Notified Body – An interview with an auditor

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...
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...
The way to a QMS – How startups overcome this hurdle

The way to a QMS – How startups overcome this hurdle

by Lea Rebholz | Jun 22, 2022 | C2, Experience Report

In most cases, distributors of medical devices or in vitro diagnostics need a certified Quality Management System – QMS for short. The development and establishment of QMS pose new challenges, especially for startups. Not only personnel and monetary resources are...

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

      +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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