Medical Device Instructions for Use Plain Language Writer

Draft patient- or clinician-facing medical device instructions for use with plain language, warnings, setup steps, and review questions.

Prompt Template

You are a medical technical writer specializing in plain-language instructions for use. Draft clear instructions for the device below without inventing claims, indications, or safety guidance.

Device name/type: [name and device category]
Intended user: [patient, caregiver, nurse, physician, technician, etc.]
Use environment: [home, clinic, hospital, field, telehealth, etc.]
Approved intended use or indication: [paste exact approved language if available]
Contraindications or users who should not use it: [if known]
Required supplies/accessories: [list]
Setup steps: [rough notes or source procedure]
Use steps: [rough notes or source procedure]
Cleaning/storage/disposal steps: [if applicable]
Known warnings or precautions: [paste source text]
Reading level and tone: [grade level, region, reassuring, clinical, etc.]
Review constraints: [regulatory, legal, brand, localization, page length]

Create:
1. IFU outline with section order
2. Plain-language setup instructions
3. Plain-language use instructions with numbered steps
4. Warning, caution, and note blocks based only on provided source details
5. Troubleshooting table for common user issues
6. Cleaning, storage, and disposal copy if relevant
7. Quick-start card version
8. Comprehension check questions for usability testing
9. List of missing source details that must be confirmed before publication

Do not provide medical advice beyond the provided source material. Flag anything that needs clinical, regulatory, or legal review.

Example Output

# Instructions for Use Draft: Home Glucose Meter Starter Kit

Before You Begin

Use this meter only with the test strips listed on the product label. Wash and dry your hands before testing. Do not use a strip if the package is torn, wet, or past its expiration date.

Test Your Blood Glucose

1. Insert a new test strip into the meter.

2. Wait for the blood drop symbol to appear.

3. Use the lancing device as directed by your clinician.

4. Touch the edge of the strip to the blood drop.

5. Wait for the result to appear on screen.

6. Record the result if your care team asked you to keep a log.

Troubleshooting

| Problem | What it may mean | What to do |

|---|---|---|

| Meter does not turn on | Battery may be low or inserted incorrectly | Replace or reinsert the battery, then try again |

| Error after applying blood | Not enough sample or strip moved too soon | Use a new strip and repeat the test |

Must Confirm Before Release

- Exact approved intended-use statement

- Required disposal language for lancets by region

- Customer support phone number and hours

Tips for Best Results

  • 💡Ask for the approved indication and warning source text before drafting final copy.
  • 💡Use short numbered steps and one action per step for usability testing.
  • 💡Separate warnings from helpful tips so users can quickly spot safety-critical information.
  • 💡Flag missing clinical or regulatory details instead of filling gaps from general knowledge.