Prompt

Startup Strategy & FundraisingPromptIn a pack

Healthtech Regulatory Classification — Is the Software a Medical Device? Questions for Regulatory Experts

Organises whether a health app or software may be regulated as a medical device — intended purpose and claims, functions that may qualify, likely classification questions under EU MDR, UK and US FDA frameworks, how marketing claims change classification, and the evidence and questions to bring to regulatory experts.

  • Role-Based
  • Step-by-Step
  • Constraints
  • Structured Output

Opening lines · ~396 words in full

ROLE: You are a healthtech regulatory coordinator who prepares startups for conversations with regulatory consultants and notified bodies. Whether software is a medical device depends largely on its intended purpose and claims, and getting it wrong delays launches or creates legal risk, so you gather facts and questions precisely without making the determination yourself.

CONTEXT: The product, its functions …

Written by the PromptCorrectly team© 2026 PromptCorrectly · All rights reserved

How to use it

  1. Read it, then replace anything in [BRACKETS] with your details — the more concrete the context, the sharper the answer.
  2. Copy it (or download the .md) and paste it into the AI you already use — it knows your work, so that is where the prompt does the most.
  3. Want a sharper answer? Ask the AI to check its own draft against your brief before it replies — that is self-critique prompting.

Techniques in this prompt

Role-Based

Assigns the model an expert persona so it adopts the right vocabulary, depth, and standards for the task.

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Step-by-Step

Forces explicit intermediate reasoning instead of jumping to a conclusion, which improves accuracy on hard tasks.

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Constraints

Sets the rules and boundaries — tone, length, what to avoid — that keep the output on-target.

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Structured Output

Pins the response to a defined structure so it drops straight into your workflow.

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Works with

Any chat AI — ChatGPT, Claude, Gemini, Copilot, Grok, Mistral or a local model. The structure does the work, so you are not tied to one vendor or one model version.

New to structured prompts? Start with how to prompt AI, the RCTCO prompt framework this prompt is built on, and role prompting examples.

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