Team Workspace
Connect your team to one workspace. Colleagues, consultants, and your QA lead work from the same file and see the same score.
The development infrastructure for medical innovation.
Connect your team, evidence, and development decisions in an AI-native workspace built for medtech.
Helping early stage teams make better design, testing, and documentation decisions before submission pressure begins.
The Platform
Everything Your Submission Needs, in One View
Classification and Pathway
Your device class and pathway for FDA and Health Canada, with the closest cleared predicate.
Readiness Score
A live score across six regulatory dimensions shows how close you are to a file you could submit.
Next Best Action
Documents, evidence, and decisions turned into one prioritized plan, with the highest impact step first.
Standards and Testing Map
The standards and tests reviewers expect, sequenced for every gate.
Product Features
See How the Work Gets Done
Hover over to stop animation
SOP Drafting
Create SOPs from your answers. Draft the procedures your quality system needs and track every one in a single list.
Manufacturer Network
Connect with manufacturers. Find partners that fit your device and the quality requirements it carries.
Classification
Classify your device. A short set of questions gives you a class and pathway for FDA and Health Canada.
Readiness Score
Know your readiness. A live score across six regulatory dimensions shows how close you are to a file you could submit.
Who We Serve
Built for Everyone Who Moves a Device Toward Market
Institutions
Universities, accelerators, incubators
87%
of Canadian institutions report at least one obstacle to commercializing their research. Half say they lack the expertise.
Fjord IQ gives every team in a cohort a regulatory plan from day one, and shows you which teams are ready.
Statistics Canada, 2026, experimental estimates
Individual Organizations
Startups and device companies
2 in 3
510(k) submissions draw questions from FDA on the first review cycle. Answering took sponsors 66 days on average in FY2025.
Fjord IQ scores your readiness and flags the gaps before the file goes in.
63% to 68% of 510(k)s, FY2018 to FY2022: Won and Lenz, 2023. Response time: FDA, 2026
Governments
Regulators and public agencies
3×
The most serious medical device recalls in the United States more than tripled in five years, from 37 in 2020 to 125 in 2025.
Fjord IQ brings regulation into the design stage, where many of these problems begin, so safer devices reach patients.
FDA, openFDA device recall reports, 2026. Class I recalls, where use can cause serious harm
Manufacturers
Contract and device manufacturers
73%
of design related recalls would have been prevented by proper design controls, an FDA expert panel found.
Fjord IQ streamlines design transfer, so devices reach you with their documentation in order, and brings you teams that are ready to build.
FDA, 1996, quality system regulation final rule
Supporting medical innovators at every stage. Develop your device on a connected platform that grows with your team—from research to commercialization.
Build Regulation into Your Product Plan from Day One
Talk to an ExpertAbout 77% of the average cost of taking a 510(k) device from concept to clearance goes to activities that depend on or relate to regulatory authorities. The earlier a team plans for it, the more of that cost it controls.
Makower et al., 2010, a survey of 204 device companies
One platform.Every layer of regulatory intelligence.
Core Capabilities
Powering Every Step of Your Regulatory Plan
Regulatory Product Blueprint
One structured view of your device, its class, and what its pathway requires.
Evidence Gap Analysis
See what regulators will expect that you have not yet produced.
Next Best Action
Documents, evidence, and decisions turned into a prioritized readiness plan.
How It Works
From Your First Product Decision
to Your Final Submission
ClassifyBoth jurisdictions
Six steps. One sequence. No guesswork.
The rating framework tells you where you stand, and the data tiers list tells you exactly what to do next.
Why Fjord IQ
Built for product decisions at the earliest stage.
Not paperwork after the fact.
Traditional QMS starts when your company is ready to manage compliance. Fjord IQ turns regulation into product direction from day one.
Core capabilities
Fjord IQ™
Traditional QMS
Fjord IQ™
Traditional QMS
Useful before a quality system existsYesAbsent
Device classification for FDA and Health CanadaYesAbsent
Standards and testing map for your deviceYesAbsent
Readiness score that updates as you workYesAbsent
Prioritized next best actionYesAbsent
Our Mission
Building the Regulatory Infrastructure for Early-Stage Decision Making
Regulatory decisions made at the start fix the cost of everything that follows. Fjord IQ moves classification, predicate selection, and testing strategy to the beginning, so every phase builds on the one before it.
Watch on YouTube →- 01Discovery and ideation. Classify the device and choose its pathway.
- 02Development and verification. Run the tests that answer the right questions.
- 03Submission and clearance. File with the gaps already closed.
- 04Market entry. Arrive with the evidence regulators expect.
“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.”
Questions
What Teams Ask Before They Start
Does Fjord IQ replace a regulatory consultant?
No. Fjord IQ is not a substitute for a licensed regulatory professional. It does the early, repeatable work, such as classification, your pathway, the standards and testing map, and first drafts, so the time you spend with a consultant goes to review and judgment.
Which regulators does it cover?
FDA in the United States and Health Canada. Every device is classified for both from day one.
What can I do before I talk to anyone?
Create an account and classify one device on your own. You will see its class under FDA and Health Canada, your submission pathway and what it requires, the closest already cleared predicate, your readiness score with a preview of your gap list, and the first lesson of our Regulatory Affairs 101 course.
How much does it cost?
Plans are matched to your project, so we go through them on a call with our CEO. There is no commitment, and you can start on your own first.
Where is my data stored, and who can see it?
Production data is hosted in Canada, encrypted at rest and in transit, and scoped to your own account. Every detail, including each subprocessor, is on our Trust and Security page.
Can my team and advisors work in it with me?
Yes. Invite colleagues, consultants, or your QA lead. Everyone works from the same file and sees the same score, and adding collaborators never changes how it works.
Get Started
Take control of your pathway. Start where regulators start.
Talk to an expert. Every project is set up around your device, and adding collaborators never changes how it works.
Two Ways In
See Where Your Device Stands
Device class under FDA and Health Canada, your submission pathway, and what it requires.
Find Your Predicate
The closest device already cleared, plus your readiness score and a preview of your gap list.
Walk Through It Together
Bring your device to a call and see the full platform, from the testing map to document templates.
Learn the Basics
The first lesson of our Regulatory Affairs 101 course comes with every account.
Supported By
