Avoid Delays. Fix Usability Gaps Now.
Ensure IEC 62366-1 & FDA compliance with expert usability validation.
UI/UX + IFU peer review for MedTech. Fast turnaround. Actionable insights. Remote or on-site.
Human Factors Advisory Panel & External Usability Peer Review Help You With
- Heuristic evaluation (Nielsen + FDA-specific)
- IFU and UI/UX analysis for IEC 62366-1 compliance
- Human Factors Risk Analysis (ISO 14971 aligned)
- Actionable issue list with severity ranking
- Recommendations for onboarding, accessibility, and labelling
- Optional: Wireframes + mockups, HF risk updates, or regulatory file support
Who It’s For:
Medtech, diagnostics, instrumentation, or wearables companies preparing for verification, FDA review, or clinical adoption.
Get Your Free FDA Usability Checklist via Email
Identify 10 common usability risks that delay 510(k) submissions. Enter your email to receive the checklist instantly.
Why It Matters:
6 Usability Traps That Stall FDA Clearance
Sample Expert Review
Fixing usability early ensures compliance and avoids expensive setbacks.
- 1 issue missed at prototype = $100 in design
- Same issue post-production = $1,000+ in recalls, delays, or lost trust
Sample Expert Review
6 Usability Traps That Stall FDA Clearance
Sample Expert Review
See What an IEC 62366-1–Aligned Peer Review Looks Like
Written by human factors and medtech UI/UX experts.
Includes IFU analysis, usability risk insights, and FDA readiness recommendations.
6 Usability Traps That Stall FDA Clearance
6 Usability Traps That Stall FDA Clearance
6 Usability Traps That Stall FDA Clearance
Discover the most common usability and human factors errors flagged during reviews— and how to fix them early to accelerate FDA approval
Want to Know if We Can Help?
Send Your IFU or Screenshots for a Free Fit Assessment
Frequently Asked Questions
Please reach us at myappliedscience@gmail.com if you cannot find an answer to your question.
Turnaround in as little as 3–5 business days, depending on project size.
Yes. All submissions are protected by NDA. We’ll sign yours or send ours.
Your device UI screenshots, mobile app access, and IFU draft (PDF). We may ask for additional materials.
Yes — book a free 15-minute strategy call to align on your needs.
The Applied Science
The Applied Science is a registered partnership based in Ontario, Canada. We specialize in peer-reviewed consulting, technical validation, and regulatory support for medical devices, diagnostics, and scientific instrumentation. As a platform built by scientists, we consult MedTech, biotech, and engineering innovators. Our services include usability testing, feasibility analysis, risk reviews, and regulatory compliance consulting, all backed by senior scientific oversight. We support startups, scale-ups, and manufacturers across Canada and the United States with flexible delivery models — remote, on-site, or hybrid. Trusted by founders. Refer us to your investors. Recommend this platform to your clients. This is the go-to destination for expert-led product development, scientific guidance, and MedTech success.
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contact us at myappliedscience@gmail.com