Does it show which of our devices a standards change affects?

Yes — Portfolio Impact compares each change against the devices, licences and product codes you track, labelled Direct, Likely or Possible, with the evidence for the label.

Can we export standards data?

Yes. Standards, the change timeline and portfolio impacts each export to CSV, and fields with no published value say so in words instead of being left blank.

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.

Who it is for: Standards, quality and submissions teams maintaining conformity claims across the US and Canada.

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What is in the workspace today

Recognized standards

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One designation, both regulators

Standards are keyed by organization and designation with edition and revision set aside, so ISO 14971:2019 and ISO 14971 Third edition resolve to the same standard. FDA and Health Canada recognition then sit side by side on one page, each linking to the regulator's own record.

Changes as dated events

Each refresh is compared against the last complete snapshot, and differences become events: newly recognized, withdrawn, edition changed, status changed, limitation changed. A snapshot that could not be read completely is carried forward rather than misread as a withdrawal.

Change timeline per standard, with the previous and current published value
Where no previous value exists, the page says No previous published value rather than implying a change
CSV export of standards, changes and impacts, with absences stated in words

Portfolio impact

Standards changes are scored against the devices, licences and product codes on your watchlists as Direct, Likely or Possible impact, so a change is a task list rather than a newsletter.

Where the data comes from

Only published regulator records, retrieved from official sources. Every screen links back to the record it came from.

FDA Recognized Consensus Standards database
Recognition numbers, designations, editions, extent of recognition and transition dates.
Open the regulator source
Health Canada recognized standards
Canadian recognition of the same designations, where published.
Open the regulator source

What this module does not do

Health Canada's recognition page has been unavailable at the source at times, so Canadian recognition can be behind FDA's. The page states which side is stale rather than presenting both as current.
Standards refresh weekly.

Questions

Does it show which of our devices a standards change affects?: Yes — Portfolio Impact compares each change against the devices, licences and product codes you track, labelled Direct, Likely or Possible, with the evidence for the label.
Can we export standards data?: Yes. Standards, the change timeline and portfolio impacts each export to CSV, and fields with no published value say so in words instead of being left blank.

Related modules

QMSR enforcement

FDA inspection citations, published observations and medical device warning letters, classified Pre-QMSR or QMSR-era, mapped to a quality-system taxonomy and linked to the companies named.

Watchlists and alerts

Watch devices, licences, companies and FDA submissions, and get alerts with Info, Attention and Critical severity, email digests and push notifications when the regulator record changes.

All six modules are in the platform overview, and every plan includes the full source history — see pricing.