FDA & Health Canada · Licences · Recalls · Standards · Enforcement

Medical device regulatory intelligence, traceable to the source

MedTech Signal brings FDA and Health Canada device authorizations, recalls, recognized standards, QMSR enforcement and AI/SaMD study evidence into one reviewable workspace — refreshed on a daily and weekly schedule, based on available public regulatory data, with every field linked back to the regulator record it came from.

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14 days free, no card needed — Canadian licences, devices, recalls, watchlists and the full alert feed for up to 3 users.

Free weekly email: new recalls and FDA actions

Every Monday: new Health Canada recalls, FDA recalls and FDA warning letters, each linked to the regulator. No account needed.

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Health Canada licences: 74,283
Device identifiers: 3,164,799
FDA authorizations: 234,262
Recognized standards: 1,585
Enforcement findings: 2,099
AI-enabled devices: 1,614
UK registered manufacturers: 13,149
UK safety alerts: 847
Device clinical trials: 76,942

Regulatory evidence is public. Finding it isn't.

Licence databases, recall notices, recognized standards lists and enforcement records sit in separate portals, each with its own identifiers, states and update cadence. Teams rebuild the same spreadsheet every quarter, and a stale row can send a submission or a distribution decision the wrong way.

MedTech Signal keeps those records normalized, compared against the previous snapshot and attached to the watchlists your team actually monitors — without inventing conclusions the records don't support.

Who it's for

Built for the people accountable for what the regulators published

MedTech Signal is not a data dump and not a consultancy. It is the working record for the teams whose decisions depend on regulator records being current, complete and checkable — whether their product is hardware, software or the data between them.

Regulatory affairs and quality teams at manufacturers

You hold the licences and clearances. MedTech Signal keeps the regulator record behind each one in one place — statuses, identifiers, standards and enforcement — refreshed on a schedule, so the quarterly spreadsheet rebuild stops being your job.

Market access and business development

Before a launch or a distribution deal, you need to know what appears to exist on the other side of the border. MedTech Signal scores the cross-border candidates and shows the reasoning, so the go/no-go conversation starts from evidence instead of a search engine.

Distributors and importers

You sell devices another company licensed. Watch each licence you depend on and hear the same day the refresh picks up a recall, a licence moving to archived or an identifier change — before your customers ask.

RA/QA consultants

Benchmark a client against what FDA actually published: which citations companies like theirs received, before and after QMSR, which consensus standards changed editions, and where their evidence sits next to authorized competitors.

AI and digital-health product teams

FDA's AI list says who was authorized, not on what evidence. MedTech Signal reads the decision summaries and lines the study designs, cohort sizes and performance metrics up side by side, each value with its page and excerpt.

Software as a medical device (SaMD) companies

Your product is code, but the regulatory record is the same shape: clearances, predicates, standards and enforcement. Research predicates in your product code, benchmark the evidence authorized devices presented, and watch the standards (IEC 62304, ISO 14971) your lifecycle depends on.

Firmware and embedded-software providers

You ship software into devices another company licenses. The enforcement themes that hit software — cybersecurity, change control, UDI, software validation — show up in FDA warning letters and inspection citations. Track them, and watch the standards editions your customers will ask you about.

Data processors, cloud and AI service providers

You process health data or supply AI capability into regulated products. The FDA AI-enabled device list is your map of who the regulated players are, what they built and what evidence convinced the regulator — a prospecting and partnership list with the source documents attached.

CDMOs, ODMs and component suppliers

Your customers' clearances, recalls and warning letters are your revenue risk. Watch the companies you supply and hear the same day a refresh picks up a recall, a warning letter or a licence change — before the next quarterly business review.

Precise use cases

Moments where the work happens

Each one starts from a situation you will recognise, names what MedTech Signal does at that moment, and links to the module that does it.

01
You cleared a device with FDA and want to sell it in Canada
Search the device once and see the apparent Canadian counterpart — licence, class, holder — or a plain No apparent match with the evaluation behind it. Save the search and let the daily refresh tell you when that changes.
How matching works →
02
A recall is published for a device you distribute
The recall is matched to the device record by identifier or normalized name and lands in your alert feed with severity, the previous and new value, and a link to the Health Canada notice. Push notification on critical recall matches, paid plans.
See alerts →
03
Your QMSR transition audit is coming up
Pull the enforcement history for companies like yours: inspection citations and warning letters mapped to a quality-system taxonomy, separated into Pre-QMSR and QMSR-era, with links to each FDA record.
See the tracker →
04
A standard your submission relies on changed editions
The change appears as a dated event with the previous and current published value, and Portfolio Impact flags which of your watched devices it appears to touch — Direct, Likely or Possible.
See standards →
05
You're writing the evidence plan for an AI/SaMD submission
Compare your planned study against two to ten authorized devices on design, cohort, validation and performance — every extracted value shown with its FDA document, page and excerpt, marked review recommended.
See the benchmark →
06
You're preparing for the EU MDR
Search EUDAMED manufacturers, devices and certificates, run the MDR compliance checklist against live FDA enforcement on each topic, and claim cross-border EU matches into your own review queue.
Open the checklist →
07
You're building software that will be regulated as a device
Look up clearances in your product code, read the decision summaries of the AI-enabled devices already authorized, and benchmark your planned study against theirs — design, cohort, validation, performance — before you write the protocol.
See the evidence benchmark →
08
You supply firmware into regulated devices
Track the standards editions your customers build against (IEC 62304, ISO 14971) with dated change events, and watch the enforcement themes that hit software — cybersecurity, change control, software validation — in FDA warning letters and citations.
See standards →
09
You process health data and want to know who the regulated players are
The FDA AI-enabled device list, read into decision summaries, shows which companies were authorized, what they built and what evidence they presented — a prospecting and partnership map with the source documents linked.
See who's authorized →

Platform

Six connected modules

Each module has its own page covering the sources behind it, how matching works and what it deliberately does not claim. Platform overview.

Market intelligence: FDA ↔ Canada

Company-level FDA to Health Canada candidate matching with scored evidence, and device-level candidates on the FDA records evaluated so far. Absence of a match is shown as No apparent Canadian match — never as an assertion that a device is unlicensed. Your review decisions persist.

Canada compliance

Health Canada MDALL licences, devices and identifiers with active and archived states preserved, Health Canada recall records matched by identifier, catalogue number and normalized company name as Matched, Possible match or No apparent match, plus watchlists and an alert feed.

Recognized standards

FDA and Health Canada standards recognition side by side, with a change timeline covering new recognitions, withdrawals, edition, status and limitation changes. Health Canada's recognition page is currently unavailable at the source, so its recognitions may be behind FDA's.

QMSR enforcement

FDA inspection citations, published observations and warning letters, kept distinct across Pre-QMSR and QMSR-era inspections and mapped to a controlled finding taxonomy. FDA publishes only part of its inspection record, so counts reflect what FDA has published, not all inspections.

AI / SaMD evidence benchmark

Compare devices from the FDA AI-enabled device list on study design, cohort size, external validation and performance metrics. Values are machine-extracted from FDA decision summaries, review recommended, and each one shows its document, page and excerpt. Fields absent from the documents read Not found in public documentation.

Watchlists and alerts

Watch the devices, licences and companies your team owns, and each scheduled refresh reports what moved in an alert feed with Info, Attention and Critical severity, unread tracking, configurable email digests and push notifications for critical recall matches on paid plans.

How it works

From regulator record to reviewed decision

01
Sources refresh on a schedule
Eight regulator sources are scheduled — licences and recalls daily, authorizations, standards and enforcement weekly. Each source shows its own last successful refresh, so a failing or partial source is visible rather than hidden.
02
Changes are detected, not guessed
Each refresh compares against the last good snapshot. Deterministic rules — no model inference — produce licence, identifier, recall, standards and impact events with Info, Attention or Critical severity.
03
Your watchlists collect what moved
Watch devices, licences and companies, and see matching changes in the alert feed with unread tracking. Email delivery is configurable per category (immediate, daily digest, weekly digest or off) and queues each event once; outbound email is sent from info@mdsignal.org.
04
Every claim is checkable
Device and record pages show the source records side by side and link back to the originating regulator page, so a reviewer can verify a field in one click.

Built for review

Careful wording, on purpose

Documented in public FDA materials

A value stated in a published document, shown with its page number and excerpt.

Not found in public documentation

Absent evidence is reported as absent, never counted as a negative finding.

Machine-extracted, review recommended

Extracted values stay visibly unconfirmed until a person reviews them, and keep their original wording.

No apparent Canadian match

Where no Health Canada record can be matched, that is all we say — never that a device is unlicensed.

Based on available public regulatory data

Coverage is limited to what each regulator publishes, and each screen shows the last successful refresh behind it.

Frequently asked

Which regulators are covered?

Health Canada and the U.S. Food and Drug Administration today: MDALL licences and device identifiers, Health Canada recalls and recognized standards, FDA 510(k)/De Novo/PMA authorizations, FDA recognized consensus standards, FDA inspection and warning-letter enforcement data, and the FDA AI-enabled device list. Coverage is limited to what each regulator publishes.

Is the data real-time?

No. Sources refresh on a schedule — licences and recalls daily, authorizations, standards and enforcement weekly — and each screen shows the last successful refresh for the source behind it. Where a source has not refreshed successfully, the workspace says so rather than presenting the data as current.

Where does the data come from?

Only published regulator records, retrieved from official sources. MedTech Signal normalizes and organizes them, based on available public regulatory data, and links each screen back to the original record.

Does MedTech Signal tell me a device is unlicensed?

No. Cross-border relationships are candidates for your review, labelled Matched, Possible match or No apparent match. MedTech Signal never asserts that a device is not licensed.

How is the AI/SaMD evidence produced?

Study designs, cohort sizes and performance metrics are machine-extracted from FDA decision summaries — review recommended — and shown with their document, page and excerpt. Extraction covers a growing subset of the FDA AI-enabled device list, and values absent from the documents read Not found in public documentation.

Is this regulatory advice?

No. MedTech Signal summarizes published regulator records for information only. Confirm anything you rely on against the linked regulator record.

Create your workspace

Sign up, add the devices, licences and companies you already track, and each scheduled refresh reports what changed in your alert feed. Plans from $299 per month (or $249 per month billed annually) per workspace — see pricing for what each tier covers.

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