Intended Use & Multi-Disciplinary Expertise
GMLP Principle 1. Get the intended use definition precise, and assemble the multi-disciplinary expertise that the device demands across the total product life cycle.
Overview
Intended use is the single most important sentence in your regulatory filing. Vague intended use produces vague evidence requirements, ambiguous claims, and review cycles that ratchet wider on every iteration.
We help craft it with the precision regulators expect and the breadth your team needs to operate against. Then we map the expertise required to deliver it (clinical, engineering, data, regulatory, human factors) and surface where you are short.
Our Process
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1
Intended use drafting
Iterate against use scenarios and likely review questions.
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2
Use scenario expansion
Foreseeable use, foreseeable misuse, edge users.
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3
Multi-disciplinary expertise map
Per scenario, the disciplines needed across the life cycle.
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4
Gap analysis
Where your team is short and how to fill.
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5
Documentation
Intended use statement and expertise map as living artifacts.
Frequently Asked Questions
Why is intended use so consequential?
Every downstream artifact (risk file, validation plan, labeling) flows from it.
How does this align with IMDRF?
Directly grounded in IMDRF/AIML WG/N88 FINAL: 2025 Principle 1.
Can intended use change over time?
Yes, through change control with documented rationale.
How do we know we have the right expertise?
Mapped against IMDRF expectations and our experience across analogous products.
Define intended use like everything depends on it. Because it does.
Send us your current intended use and team composition. We will return a refined statement and expertise gap analysis within three weeks.
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