Short answers for the medical-device questions founders actually search.
These guides are the traffic layer for TrueMedDevice. Each one answers a focused FDA, 510(k), Health Canada, recall, or market-entry question, then helps the reader generate a free custom report for their own product.
Catch search demand
Each page answers one concrete question in plain English before routing the reader to a product-specific next step.
Convert into a free report
The primary call to action is not a sales call. It is a free custom report for the reader's own device and question.
Learn from real behavior
Guide query, click, report-generation, and paid-upgrade signals become the next writing queue.
Start broad enough to catch demand, specific enough to convert.
Do I need FDA clearance for my medical device? A 5-minute check
A plain-English founder check for whether a medical-device product may need FDA clearance, approval, exemption review, or a different next step.
510(k) small business fee: how to check the FY2026 reduced rate
Check the FDA FY2026 510(k) standard fee, small business fee, and Small Business Determination steps before paying.
MDL vs MDEL Canada: which one does my device need?
A plain-English guide to Medical Device Licence (MDL) and Medical Device Establishment Licence (MDEL) questions for Canada market entry.
I sold my device in the US without clearance. Now what?
A crisis-search guide for founders who may have sold or marketed a medical device in the United States before resolving FDA status.
How long does FDA 510(k) really take?
A simple planning guide for 510(k) timing, review clocks, testing, consultant preparation, and avoidable delay.
Predicate device search: 3 steps before calling a consultant
Use FDA 510(k), product-code, and similar-device clues to prepare a better consultant call before spending paid review time.
What happens at an FDA inspection after clearance?
A founder-friendly guide to post-clearance inspection questions, quality system evidence, complaint files, and review preparation.
Health Canada medical device licence: cost and timeline 2026
A founder guide to Health Canada Medical Device Licence planning, cost categories, timeline questions, and evidence preparation.
My competitor got a recall. Should I worry?
A practical guide for turning competitor recalls into product, quality, risk, and market-entry review questions.
When do I need a 513(g) instead of assuming my product is not a device?
A boundary-question guide for founders who are unsure whether a product is a medical device or what classification pathway may apply.
These guides are preparation support, not regulatory or legal advice.
They help founders organize public sources, product facts, assumptions, and questions before qualified review. They do not decide product code, classification, predicate suitability, clearance, approval, licence eligibility, safety, effectiveness, compliance, or legal status.