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Medical Device Manufacturers

Patients and caregivers often use your device at home, with no one to ask. Clear steps and warnings help them use it safely. HealthLiteracyCopilot checks your instructions and patient materials against health-literacy standards and your own labeling rules, and keeps a record of each review.

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HealthcareGPS is SOC 2 Type II audited and HIPAA compliant. How we protect your documents

Sketch of instructions for use with a warning box at the top and three numbered steps, each with a small picture.Warning123Warning firstOne actionper step

What we fix

Instructions for use, one step at a time

  • The warning comes before the step it belongs to.
  • One action per step, with a picture beside it.
  • Checked against your own labeling rules, with a record of each review.

Illustrative example.

Documents we review

Open a document type to see what we check in it, with a short synthetic example.

Instructions for useThe full guide people follow at home.

What we check

  • Reading grade against your target, with long sentences flagged.
  • Numbered steps, one action each, in the order people do them. PEMAT actionability shows where readers get stuck.
  • Each warning placed before the step it applies to.
  • Protected regulatory text kept word for word.

Synthetic example

Before
Prior to initiating therapy, ensure the reservoir has been adequately primed in accordance with Section 4.
After
Before you start: 1. Fill the reservoir. 2. Press Prime until you see a drop at the tip.
Quick-start guidesThe first page people read, often the only one.

What we check

  • A clear first step, then one action per step.
  • Plain words in place of terms like "actuate", or a short definition from your glossary.
  • Times, settings and amounts listed as numbers to verify, so a person checks each one.

Synthetic example

Before
Actuate the device and maintain pressure for a minimum of 10 seconds.
After
Press and hold the button. Count to 10 before you let go.
Safety informationWarnings, and when to get help.

What we check

  • The action first: what to do, then why.
  • After each edit, numbers, steps and "do not" rules are compared with the source.
  • Required warning text, as your labeling rules set it, kept word for word.

Synthetic example

Before
Failure to discontinue use upon observation of skin irritation may result in adverse sequelae.
After
Stop using the patch if your skin turns red, itches or blisters. Then call your care team. Skin problems can get worse if you keep using it.
Care and cleaning guidesHow to keep the device clean and working.

What we check

  • Numbered steps with times and amounts people can check.
  • Plain names for supplies, such as "mild soap".
  • A clear "do not" for anything that could damage the device.

Synthetic example

Before
Utilize a non-abrasive cleansing agent and abstain from submersion of the unit.
After
Wipe it with a soft cloth and mild soap. Do not put it under water.
Troubleshooting pagesWhat to do when something goes wrong.

What we check

  • Each problem paired with one clear action.
  • When to call support or a clinician, said plainly.
  • Error codes and phone numbers listed as numbers to verify.

Synthetic example

Before
In the event of an E4 notification, the user should attempt to re-establish connectivity prior to contacting technical support.
After
See E4 on the screen? Turn the device off, then on. Still see E4? Call support at [phone].
Patient training materialsWhat staff use to teach patients and caregivers.

What we check

  • Reading grade against the target you set for this audience.
  • Spanish measured as Spanish, with Fernández-Huerta, INFLESZ and SOL, not English formulas.
  • Word and HTML files checked against WCAG 2.1 AA, with a reviewer deciding each finding.

Synthetic example

Before
Patients should be instructed regarding appropriate site rotation to mitigate the risk of lipohypertrophy.
After
Use a new spot each time. This helps keep lumps from forming under your skin.

Synthetic examples, written for this page. Your team approves every edit before it is used.

What we check

  • Steps people can follow

    One action per step, in order, with a clear next step. PEMAT actionability shows where readers get stuck.

  • Warnings that stay intact

    After each edit, numbers, steps and "do not" rules are compared with the source.

  • Your labeling rules

    Checks against your labeling and plain-language rules, with a review record.

  • Every language

    Content in 45 languages and regional variants. A human translator handles any text where a dose, number or "do not" could be lost.

What you get

  • Tracked-change Word files

    Each suggested edit shows its reason. Your team approves or rejects it.

  • A review record

    The score, the version, the reviewer and the date for each document.

  • Accessibility checks

    Word and HTML files checked against WCAG 2.1 AA, with a reviewer deciding each finding.

See a reviewed document first

Step through a finished review of a sample health plan letter: the findings, each proposed edit, the reviewer's decisions and the report.

See a reviewed sampleTalk to our team

HealthcareGPS is SOC 2 Type II audited and HIPAA compliant. How we protect your documents

Frequently Asked Questions

How does HealthLiteracyCopilot help medical device manufacturers?

It scores instructions, safety information and user guides against health-literacy standards, suggests plain-language edits your team approves, and keeps a record of each review.

Does a review mean our labeling meets FDA rules?

No tool can promise that. It checks your materials against your labeling and plain-language rules, a named reviewer decides, and you keep the record. Your regulatory team makes the call.

Can it adapt content for global audiences?

Yes. It translates into 45 languages and regional variants, and sends risky text to a human translator.