Medical device UX testing proposal: Free template
Customize this free medical device UX testing proposal with Cobrief
Open this free medical device UX testing proposal in Cobrief and start editing it instantly using AI. You can adjust the tone, structure, and content based on your client’s device class, regulatory needs, and intended user group. You can also use AI to review your draft — spot gaps, tighten language, and improve clarity before sending.
Once you're done, send, download, or save the proposal in one click — no formatting or setup required.
This template is fully customizable and built for real-world use — ideal for helping medtech companies, design teams, or regulatory consultants conduct user experience (UX) testing for new or updated medical devices. Whether you're testing a diagnostic tool, wearable, or connected platform, this version gives you a structured head start and removes the guesswork.
What is a medical device UX testing proposal?
A medical device UX testing proposal outlines your plan to evaluate how users interact with a medical device in real-world or simulated conditions. It typically includes test planning, participant recruitment, usability protocols, data collection, task analysis, safety signal tracking, and reporting suitable for regulatory submission (e.g. FDA Human Factors guidelines).
This type of proposal is used by UX researchers, regulatory consultants, and medtech product teams supporting device development, validation, or redesign.
Use this proposal to:
- Identify usability issues that could impact safety, effectiveness, or adoption.
- Document task completion rates, error paths, and user feedback for FDA or CE review.
- Improve interface design and workflow clarity for clinicians or patients.
- Reduce risk of user error and improve product acceptance in clinical settings.
This proposal helps clients go beyond aesthetics — and uncover critical insights for safe, intuitive design.
Why use Cobrief to edit your proposal
Instead of copying a static template, you can use Cobrief to tailor and refine your proposal directly in your browser — with AI built in to help along the way.
- Edit the proposal directly in your browser: No setup or formatting required — just click and start customizing.
- Rewrite sections with AI: Highlight any sentence and choose from actions like shorten, expand, simplify, or change tone.
- Run a one-click AI review: Get instant suggestions to improve clarity, fix vague sections, or tighten your message.
- Apply AI suggestions instantly: Review and accept individual AI suggestions, or apply all improvements across the proposal in one click.
- Share or export instantly: Send your proposal through Cobrief or download a clean PDF or DOCX version when you’re done.
Cobrief helps you create a polished, persuasive proposal — without wasting time on formatting or second-guessing your copy.
When to use this proposal
This medical device UX testing proposal works well in situations like:
- When preparing a new Class I, II, or III medical device for FDA or CE mark submission.
- When redesigning a legacy product with a new interface or user workflow.
- When evaluating user interaction with hardware + software combos (e.g. wearables, connected monitors).
- When conducting summative (validation) or formative (exploratory) usability testing.
- When collecting data for internal safety review, labeling updates, or investor milestones.
Use this proposal to help clients reduce risk and meet both design and regulatory expectations.
What to include in a medical device UX testing proposal
Each section of the proposal is designed to help you explain your offer clearly and professionally. Here's how to use them:
- Executive summary: Present UX testing as essential for improving safety, reducing user error, and preparing for regulatory review.
- Scope of work: Include test plan development, user profile creation (e.g. clinician, patient, caregiver), protocol design, environment setup (lab or remote), task flow creation, risk-based scenarios, observation and data logging, post-test interviews, analysis, and reporting aligned with FDA or MDR expectations.
- Timeline: Break into phases — planning, recruitment, testing, analysis, and report delivery. Typical timelines range from 3–6 weeks depending on complexity and participant count.
- Pricing: Offer flat-fee or per-device pricing. Optional add-ons: video documentation, statistical analysis, regulatory gap review, updated IFU feedback, or follow-up testing.
- Terms and conditions: Clarify IRB/ethics considerations, data use and privacy, hardware provisioning (if needed), participant incentives, and responsibilities for logistics.
- Next steps: Include a CTA like “Approve to begin test plan drafting and participant screening” or “Schedule kickoff to align on device classification, user groups, and testing context.”
How to write an effective medical device UX testing proposal
Use these best practices to show regulatory alignment, research expertise, and clinical awareness:
- Make the client the focus: Show how testing reduces regulatory risk, improves real-world adoption, and supports successful go-to-market.
- Personalize where it matters: Reference device class, intended users (e.g. nurses, patients, caregivers), and usage setting (home, hospital, clinic).
- Show results, not just deliverables: Use examples like “Resolved 5 out of 6 task-critical usability issues prior to submission” or “Improved task success rate from 68% to 95%.”
- Be clear and confident: Avoid vague phrases like “optimize interface.” Specify which tasks are being tested and how results will be analyzed and reported.
- Keep it skimmable: Use phased plans and scoped deliverables for quick internal or cross-functional approval.
- End with momentum: Recommend starting with formative testing or a small user group to de-risk summative testing later on.
Frequently asked questions (FAQs)
What client inputs should I gather before customizing this proposal?
Confirm the device class, target users, known risk points, intended use environment, whether testing is formative or summative, and submission timelines (if applicable).
What kind of testing environment should I recommend?
Depends on use case. Clinical devices may require simulated clinical space; home-use devices may need remote or in-situ testing. Recommend what reflects actual usage best.
Should I include IRB approval or ethics submission in scope?
For summative testing, yes — if human factors guidance or institutional policy requires it. For formative testing, it’s often not required but may still benefit from documentation.
What deliverables should I include at the end of the project?
Summary report with findings, error taxonomy, mitigation recommendations, raw usability data (anonymized), and a submission-ready validation report if needed.
Can I reuse this proposal for non-regulated digital health UX testing?
Yes — just remove references to FDA or MDR, and tailor for app-based or digital-only workflows. The core structure still applies.
This article contains general legal information and does not contain legal advice. Cobrief is not a law firm or a substitute for an attorney or law firm. The law is complex and changes often. For legal advice, please ask a lawyer.