Platform

Six modules, one record of what the regulators published

Each module reads official sources on a schedule, detects what changed against the last good snapshot, and links every field back to the regulator record behind it. Where the published data does not support a conclusion, the workspace says so instead of guessing.

Canada compliance

Health Canada medical device licences, devices and recalls

Health Canada's Medical Devices Active Licence Listing (MDALL) is published as a search form, one licence at a time, and archived licences live in a separate listing. MedTech Signal holds both as one searchable history.

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Market intelligence: FDA ↔ Canada

Cross-border market intelligence: FDA authorizations against Health Canada licences

The same device carries a different name, a different company spelling and a different identifier in each country. Matching those records is the work; MedTech Signal does it in the open, with a score and an explanation for every pair.

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Recognized standards

FDA and Health Canada recognized consensus standards, with a change timeline

A standard's edition changes quietly, and the consequence lands on your submissions. MedTech Signal keeps each recognition list as a dated history and tells you what changed against your own portfolio.

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QMSR enforcement

FDA QMSR enforcement: inspection citations, observations and warning letters

The Quality Management System Regulation replaced the Quality System Regulation on February 2, 2026. Enforcement history now spans two regimes, and a citation means something different on each side of that line.

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AI / SaMD evidence benchmark

AI and SaMD evidence benchmark, extracted from FDA decision summaries

FDA's AI-enabled device list tells you which devices were authorized. It does not tell you what evidence supported them. That sits inside decision summaries, as PDFs, one device at a time.

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Watchlists and alerts

Watchlists and regulatory change alerts for the records you own

Regulatory monitoring fails on volume. Watchlists narrow eight regulator sources down to the records your team actually owns, and each refresh reports only what moved.

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MedTech Signal organizes published regulator records for information only. Confirm anything you rely on against the linked regulator record.