Regulatory topic
Regulatory intelligence for software, firmware and data companies
You don't need to ship hardware to be in the regulators' records. Standalone software, firmware inside a device, and the data pipelines around them all appear in FDA clearances, recognized standards and enforcement records. MedTech Signal organizes those records so software teams can work from them directly.
Software as a device vs software in a device
SaMD is software that is itself the medical device; embedded software and firmware are regulated as part of the device they run in. Both leave a trail: 510(k), De Novo and PMA clearances, product codes, decision summaries and, when things go wrong, recalls and warning letters. MedTech Signal holds all of these and links each to the FDA record.
Benchmark the evidence before you write the protocol
The FDA AI-enabled device list says who was authorized; MedTech Signal reads the decision summaries behind it and lines up study design, cohort size, external validation and performance metrics side by side — every value shown with its document, page and excerpt, marked review recommended.
The standards your lifecycle runs on
IEC 62304 (software lifecycle), ISO 14971 (risk management) and IEC 82304 (health software product safety) are recognized by FDA and Health Canada, and several are harmonized under the EU MDR. The standards register tracks editions, statuses and dated changes, and Portfolio Impact flags which of your watched products a change appears to touch.
Enforcement themes that hit software
Cybersecurity, change control, software validation and UDI recur in FDA warning letters and inspection citations. The enforcement tracker maps them to a quality-system taxonomy, so a software team can see what inspectors actually cite — before their own audit.
For data processors and AI service providers
If you process health data or supply AI capability into regulated products, the clearance record is your map of the market: who is authorized, what they built, and what evidence convinced the regulator. Use it for prospecting, partnership due diligence and competitive awareness.
Where this goes next
Planned additional sources for software teams include Health Canada SaMD guidance tracking, EU MDCG software guidance, FDA cybersecurity premarket guidance and IMDRF SaMD categorization. These are roadmap items — they are not in the database today, and this page does not pretend they are.
Sources held today: FDA 510(k)/De Novo/PMA clearances, the FDA AI-enabled device list with machine-extracted decision summaries, FDA and Health Canada recognized standards, and FDA enforcement records — all refreshed on a schedule.