Features
Everything MedTech Signal does, on one page
MedTech Signal keeps one organized record of what the FDA and Health Canada have published about medical devices, tells you the moment something changes, and links every statement back to the regulator's own record.
01
Find a product or a company
Search the FDA and Health Canada records together, using cleaned-up names so spelling differences do not hide a record.
- Product search
- Search by product name, company or submission number across FDA clearances and Health Canada licences, devices and companies at once.
- Original vs cleaned names
- See the regulator's exact wording beside the tidied version, what differs, and a link to the published record.
- Public product lookup
- A free lookup page anyone can use before signing in.
- Every record links out
- Each licence, device, company, clearance and recall carries a link to the regulator's published page. Where a regulator publishes no link, it says so.
02
Canada compliance
Health Canada licences, devices, companies and recall notices, kept current.
- Licences and devices
- Browse active and archived Health Canada licences with their devices, identifiers and licence holder.
- Recalls and safety alerts
- Health Canada notices with hazard class, dates, the affected products and the original notice.
- Watchlists
- Track the products, licences and companies you care about — yours or a competitor's — and export any list to CSV or Excel.
- Gap analysis
- Line your watchlist up against the other regulator's records: counterpart found, possible counterpart, no counterpart found, or not compared yet.
03
Cross-border matching: FDA ↔ Canada
For any US device, what appears to exist in Canada — and the other way round — with the reasoning shown.
- Counterpart panels
- Every FDA clearance page shows its apparent Canadian counterpart; every Canadian device shows its apparent US counterpart.
- Scores and explanations
- Matching goes company name first, then close variants, then product similarity and category. Each result shows its score and the reason in plain words.
- Honest wording
- Results are Matched, Possible match or No apparent match. Nothing is ever called unlicensed or uncleared, and records never compared stay in their own group.
- Your review, kept
- Confirm, reject or pick between ambiguous companies. Decisions are recorded with who decided and when, survive every data refresh, and can be undone.
- Match history
- A full trail of what changed, what was overridden, and what was withdrawn.
- Cross-border recalls
- Canadian recall notices beside their apparent FDA counterparts, with a saved search for Canadian recalls with no apparent US match.
- US status dashboard
- One view of where every tracked Canadian device stands against the US records.
04
Alerts and inboxes
Changes come to you, grouped and explained, with the previous and the new value.
- Inbox
- Every alert for your watchlists, grouped by record kind — devices, licences, companies, FDA authorizations, recalls — with mark read, dismiss and restore.
- Recall inbox
- Recall alerts grouped by the kind of change, each opening on its own page with both regulators' records side by side.
- Alert opens the record
- Every alert links straight to the page for the record it concerns.
- Email and push
- A weekly summary by email from info@mdsignal.org, plus push notifications on your phone or desktop.
05
Recognized standards
Which consensus standards the regulators recognize, and what changed.
- Standards register
- FDA and Health Canada recognized standards with edition, status and dates.
- Changes
- New, revised and withdrawn recognitions as they are published.
- Portfolio impact
- Which of your tracked products a standards change appears to touch.
06
US enforcement and QMSR
What the FDA published about inspections, warning letters and recalls — and what it implies about the quality regime in force.
- US enforcement tracker
- Warning letters, published Form 483 inspections and FDA recalls in one list, with status, dates, company and a link to each FDA record.
- Compliance history
- For each company or authorization: regulator dates, the regime decision and its wording, reviewer decisions and every tracked change.
- Enforcement windows
- When enforcement appears to have started and ended, in the US and in Canada, worked out only from dates the regulators published. If no closeout is published, it says so rather than implying it is over.
- Regime mix
- Your tracked companies split into QMSR, pre-QMSR, undetermined and no enforcement record held, with quarterly trends and a comparison against the whole dataset.
- Findings
- Inspection observations and citations, reviewable and filterable by company.
07
AI and software as a medical device
The FDA's AI-enabled device list, with the evidence each submission relied on.
- AI-enabled devices
- The published list with the company, decision and source documents.
- Evidence benchmark
- Compare what clinical and performance evidence similar submissions presented, side by side.
- Source documents
- The decision summaries themselves, readable in place and linked to the FDA original.
08
Your workspace
Accounts, teams, plans and data provenance.
- Overview dashboard
- Your alerts, watchlists, recent recalls and the newest regulator documents on one screen.
- Team access
- Invite colleagues, with roles, and see who decided what.
- Free trial and plans
- A 14-day trial creates a real account. Paid plans unlock modules and alerts; billing and seats are visible in your workspace.
- Sources page
- Every regulator record set used, when it was last refreshed and how many records it holds.
- Install it
- Works as an installable app on desktop and mobile, with an unread badge on the icon.
- Privacy
- No analytics or third-party tracking. Cookies are used only to keep you signed in.
How we word uncertainty
Where the records do not line up, MedTech Signal says no apparent match — never that a product is unlicensed, uncleared or not recalled. Records that have never been compared are shown as not compared yet rather than counted as gaps. Every assertion carries a link to the regulator record it came from.
MedTech Signal organizes published regulator records for information only. Confirm anything you rely on against the linked regulator record.