100 lines
3.9 KiB
Markdown
100 lines
3.9 KiB
Markdown
# Intended Use
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**Document Change History**
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| Version | Date | Author | Change Comment |
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|---------|------------|----------------|----------------|
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| 0.1 | 2023-02-01 | Markus Thielen | Draft |
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## Mapping of Requirements to Document Sections
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> Only relevant if you're aiming for MDD (and not MDR) compliance:
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| MDD Class | MDD Section | Document Section |
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|---------------|------------------|------------------|
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| IIa, IIb, III | Annex II, 3.2 c) | (All) |
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| I | Annex VII, 3 | (All) |
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> And vice-versa, only relevant if you're aiming for MDR (not MDD) compliance:
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| MDR Class | MDR Section | Document Section |
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|-----------|-------------------------------|------------------|
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| (All) | Annex II, 1.1 a) - d), h), i) | (All) |
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> Always relevant:
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| ISO 14971:2019 Section | Document Section |
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|------------------------|------------------|
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| 5.2 | (All) |
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| IEC 62366-1:2015 Section | Document Section |
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|--------------------------|------------------|
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| 5.1 | (All) |
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## Product
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* Name: *\<product name\>*
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* Version: *\<product version\>*
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* Basic UDI-DI: *\<insert UDI-DI, if/when available\>*
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## Intended Use
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> Describe the core medical functionality of your device and how it treats, diagnoses or alleviates a disease.
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> Keep it high-level so that this description is true for as long as possible even when the device is updated.
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## Intended Medical Indication
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> Describe the condition(s) and/or disease(s) to be screened, monitored, treated, diagnosed, or prevented by
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> your software. Importantly, also list exclusion criteria: Maybe patients with a certain diagnosis should not
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> be using your device.
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## Contraindications
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> List anything that you want to explicitly exclude from your intended use.
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## Patient Population
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> Describe the patient population your software is intended to be used on. Note that this may overlap with the
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> user profile (section below), but not necessarily. Your software could be used by physicians to diagnose
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> diseases in patients, so in that case, they don't overlap. Some ideas for characteristics to describe: Age
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> group, weight range, health, condition(s).
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## User Profile
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> Describe the typical user of the software. Some ideas could be: Qualifications, prior training (for your
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> software), technical proficiency, time spent using the software.
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## Use Environment Including Software/Hardware
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> Describe the typical use environment. What sort of devices is this running on? Does the software only run on
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> one device or multiple devices? Is it loud and chaotic like in an emergency ward? How's the lighting?
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>
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> Also, add other software or hardware which is required by your device. Most commonly, apps require users to
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> have a smartphone with a compatible operating system (iOS / Android).
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## Operating Principle
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> It's kind of a stretch to describe the "operating principle" of software. I guess this makes more sense for
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> hardware devices. In any case, I'd just generally state what sort of input goes in and what output comes
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> out, e.g. you could be processing images and returning diagnoses.
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The device is stand-alone software. It receives input from the user and outputs information.
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## Part of the Body / Type of Tissue Interacted With
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The device is stand-alone software. It receives input from the user and outputs information. It doesn't come
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in contact with tissue or bodily fluids.
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## Variants / Accessories
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> Describe variants and/or accessories of/to this device, if applicable. For typical stand-alone software of
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> startups, this shouldn't be applicable.
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---
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Template Copyright [openregulatory.com](https://openregulatory.com). See [template
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license](https://openregulatory.com/template-license).
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Please don't remove this notice even if you've modified contents of this template.
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