Placing regulatory expertise in the hands of early stage med tech innovators.
Join our wait list to be the first to discover how to go from prototype to approval
- ISO 13485
- IEC 60601-1
- ISO 14971
- ISO 10993
- IEC 62304
- ASTM Standards
Supported by
Placing FDA & Health Canada regulatory submission expertise in the hands of every med tech innovator.
The problem
The global medical devices market will reach $717 billion by 2030, yet the regulatory knowledge required to access it remains priced out of reach for the early-stage founders building its future.
70%
Of medical device innovations never reach market
+31%
Year over year growth in software-related recalls as devices become more connected and complex.
$500/hr
Consulting costs limit early stage teams from designing with standards in mind.
Our solution
-
01
Describe your device and target market
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Get your exact standards, costs and timelines
02 -
03
Book testing at a certified partner lab
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Track progress and capture evidence in real time
04 -
05
Generate your submission package with one click
Our hypothesis
If we treat regulation as a design input, we move the entire medtech industry from accidental creation to predictable innovation — and the best ideas win instead of the best-funded ones.
Our Technology
Fjord IQ is powered by two proprietary assets. Together they translate the complexity of FDA and Health Canada compliance into a clear, prioritized roadmap specific to your device and your market.
A Rating Framework that scores your regulatory readiness across six dimensions in real time.
A Data Tiers List that sequences every test your device needs in the exact order regulators expect to see them.
Our two core assets work in concert — the Rating Framework tells you where you stand, and the Data Tiers List tells you exactly what to do next. No guesswork, no $500/hr consultant required.
Real-time confidence scores across six regulatory dimensions, updated as your project evolves.
A sequenced test roadmap that mirrors what FDA and Health Canada reviewers look for at each gate.
What we cover
Three layers.
One platform.
Fjord IQ handles the first two entirely. The third, we connect you to the right expert.
Procedural Knowledge
What standards apply. What documents you need. What the process looks like. What forms to complete. What the submission pathway requires. Which jurisdictions apply to your device. Fjord IQ handles this entirely through AI-powered standards mapping and classification logic.
Fjord IQ handles this entirely
Technical Execution
Building your QMS. Writing your risk management file. Structuring your submission. Guided module-by-module QMS completion. Template documents pre-populated with your device information. Lab report analysis that maps results to submission sections automatically.
Fjord IQ guides you through every step
Strategic Judgment
Device classification. Predicate strategy. Regulatory negotiation. Deficiency response. The calls that require experienced human judgment and regulatory precedent knowledge. Fjord IQ identifies when you need an expert and connects you to the right one at the right moment through our consultant network.
Fjord IQ connects you to the right expert
Our Mission
To democratize regulatory intelligence so that the quality of your idea — not the size of your budget — determines whether it reaches the world.
Who we serve
Meet the Founder
“If there is no innovation in regulatory, then how much innovation really is there?”
Nye T. Dafalla, CEO & Founder
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Work with us
Make regulatory compliance your competitive advantage.
Partner with Fjord IQ to bring structured regulatory readiness to your cohort, portfolio, or program.
FAQ
Regulatory intelligence. Built Together