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  1. www.johner-institut.de › blog › regulatory-affairsZweckbestimmung und bestimmungsgemäßer Gebrauch (Medizinprodukt)

    3. März 2021 · Zweckbestimmung und bestimmungsgemäßer Gebrauch: Folgenreicher als Sie denken! 3. März 2021. Expert: Dr. Juliane Havlicek. Die korrekte und präzise Formulierung der Zweckbestimmung von Medizinprodukten ist entscheidend für deren erfolgreiche Entwicklung und Zulassung.

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  2. www.greenlight.guru › blog › intended-use-and-indications-of-useThe Difference Between Intended Use and Indications of Use (And...

    Learn the difference between intended use and indications for use of medical devices, and how they affect risk classification, regulatory pathways, and reimbursement. Find out strategies for writing effective statements and listen to a podcast episode with experts.

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  4. clin-r.com › intended-purpose-intended-use-and-indicationsIntended Purpose, Intended Use, and Indications for Use | Clin R

    Learn the difference between these terms and how they affect medical device design, development, and regulation. Find out how to write clear and definitive statements for Intended Purpose and Intended Use, and how they can change the risk classification of your device.

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  5. compliancenavigator.bsigroup.com › en › medicaldeviceblogMDR clinical evaluation planning - intended purpose, indications...

    5. Jan. 2022 · 'indication’, ‘indication for use’: refers to the clinical condition that is to be diagnosed, prevented, monitored, treated, alleviated, compensated for, replaced, modified or controlled by the medical device. It should be distinguished from ‘intended purpose/intended use’, which describes the effect of a device. All ...

  6. www.mddionline.com › product-development › why-you-must-knowThe Difference Between 'Intended Use' and 'Indications for Use'

    25. Apr. 2017 · Indications for use cover the reasons or situations in which someone would use the device. Under what conditions will the product be used? This is a term that is also commonly used in other areas, such as for classifying drugs and medications.

    • Jon Speer

  7. www.meddeviceonline.com › doc › key-considerations-in-intendedKey Considerations In "Intended Use" And "Indications For Use ...

    14. Dez. 2023 · “Indications for use” are about how and when a user will use the device: the reasons and the conditions under which the device will be used. So, indications for use would specify the disease, condition, injury, or illness the device will prevent, diagnose, or treat, along with the circumstances surrounding the device’s use ...

  8. www.youtube.com › watchWhat's the difference between intended use, indications for use,...

    11. Juni 2021 · 32. 2.3K views 2 years ago Regulation (EU) 2017/745 - New EU MDR. In this video, Rob Packard and Shivani Nachane explain the difference between intended use, indications for use, and the...

    • 16 Min.
    • 2,6K
    • Medical Device Academy