Classify Your Device, Map FDA and Health Canada Requirements, and Build the Evidence Regulators Expect. From Your First Product Decision to Your Final Submission.

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Backing the founders the funding system overlooks.

Regulation Belongs at the Start of Product Design.

Helping early-stage teams make better design, testing, and documentation decisions before submission pressure begins.

  • Regulatory Product Blueprint
  • Pathway & Classification Engine
  • Next-Best Action Prioritization
  • Document Gate by Stage
  • Evidence Gap Analysis
  • Founder-to-Enterprise Intelligence Layer
  • Readiness Index Score
  • Standards & Testing Map

Traditional QMS Starts When Your Company Is Ready to Manage Compliance.

Fjord IQ turns regulation into product direction from day one.

  1. 01 ClassifyBoth Jurisdictions
  2. 02 MapStandards & Tests
  3. 03 ScoreReadiness
  4. 04 DraftFrom Your Answers
  5. 05 PrioritizeNext Best Action
  6. 06 SubmitPackage Ready

Building the Regulatory Infrastructure for Early-Stage Decision Making

Watch on YouTube →
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.

The Regulatory Intelligence Layer for Early-Stage Medical Device Decisions.

Our Technology

Pathway & Classification

Classify your device and map its FDA & Health Canada pathway from day one.

Evidence & Testing Map

Sequence the standards and tests reviewers expect at every gate.

Readiness Scoring

Track a live confidence score across six regulatory dimensions.

Next-Best Actions

Turn documents, evidence, and decisions into a prioritized readiness plan.

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 expensive consultant required.

Rating Framework

Real-time confidence scores across six regulatory dimensions, updated as your project evolves.

Data Tiers List

A sequenced test roadmap that mirrors what FDA and Health Canada reviewers look for at each gate.

Your first project is free, for good. Every project after that is one price, not per seat. Adding collaborators never changes it.

Your First Project

Everything you need before you spend a dollar

FreeOne Project Per Account
  • Device class under FDA and Health Canada
  • Your submission pathway and what it requires
  • The closest already-cleared predicate device
  • Your readiness score, plus a preview of your gap list
  • The first lesson of our Regulatory Affairs 101 course
Start Your First Project →

Full Platform

From first product decision to final submission

C$255/mo per Project (CAD)
  • Everything in your first project, unlocked in full
  • Standards and testing map, filtered to your device
  • Document templates that populate from your answers
  • Readiness score that moves as you build
  • Cost and timeline estimates for your pathway

10% off billed annually. No quality manager required, no consultant on retainer. An existing project always gets 14 days' notice before it locks. Nothing is ever deleted.

Get Full Access →
You answer six questions about your device. Fjord IQ classifies it under FDA and Health Canada, finds the closest device already cleared, and maps what yours actually requires.
The full platform turns your documents, evidence, and decisions into a prioritized readiness plan, and a score that tells you exactly where you stand.