Comparison
MedTech Signal vs FDA-only tools
FDA-only tools work well if you sell only in the US. If you also sell in Canada, or plan to, you need to know what Health Canada has licensed and recalled, and how that lines up with the FDA. That is what MedTech Signal adds.
| What you need | MedTech Signal | Typical FDA-only tool |
|---|---|---|
| FDA 510(k), De Novo and PMA records | Yes — imported from openFDA, each record linked to its FDA source page. | Yes — this is their core. |
| Health Canada licences, devices and identifiers | Yes — MDALL licences, devices and device identifiers. | Usually not covered. |
| Recall alerts | Health Canada recall alerts by email, plus an FDA recall watchlist that alerts when a tracked recall changes class, status or dates. | FDA recalls only; Canadian recalls are not tracked. |
| Canada–US cross-check | Each device gets a match label (Matched, Possible match or No apparent match), a score and an explanation, with links to both regulator records. | Not available — there is no Canadian data to compare against. |
| Other markets | UK MHRA in every plan; EU MDR / EUDAMED as an add-on. | Varies; usually US only. |
| Pricing | Published: from $299 per month. 14-day free trial, no card needed. | Varies; often available only by quote. |
"Typical FDA-only tool" describes the category in general, not any one product. Check each vendor's current features yourself.
Recall alerts for both countries
You get an email when Health Canada publishes a new recall in the categories you choose. Add FDA recalls to a watchlist to get an alert when their class, status or dates change. Every alert links to the original recall notice. See this week's recalls.
Canada–US cross-check
MedTech Signal compares FDA clearances with Health Canada licences by manufacturer, device name and identifiers. Each result is labelled Matched, Possible match or No apparent match. "No apparent match" means we found no matching record. It never means a device is unlicensed. Each label links to both regulator records so you can check them yourself. Try the cross-border demo.
Pricing
- Essentials — $299/month ($2,990/year): Health Canada monitoring, recall alerts, watchlists. Up to 5 users.
- Professional — $899/month ($8,990/year): adds FDA data and the Canada–US cross-check. Up to 25 users.
- Enterprise — $2,499/month ($24,990/year): adds FDA inspection citations, warning letters and admin controls. Unlimited users.
- EU MDR add-on — $199/month ($1,990/year).
Prices in USD, per workspace. To use the Canada–US cross-check, choose Professional or higher.
MedTech Signal is sold by Rubicon Microproducts Inc..