FOR MEDTECH TEAMS WITH AN EXISTING REGULATORY STRATEGY
Get an independent second opinion before assumptions shape the work.
Falcr builds a separate preliminary view without seeing your existing strategy. You compare the two privately.
20-MINUTE SECOND-OPINION FIT CHECK
REGULATORY PATHWAY BRIEF · SECTION 01
HUMAN-REVIEWED- 01
Likely classification for the stated intended use.
FDABASIS - 02
Premarket route implied by that classification.
FDABASIS - 03
Evidence expectations that may affect testing planning.
EU MDRASSUMPTION - 04
Intended-use wording that changes the outcome by jurisdiction.
TGAUNCERTAINTY - 05
Points public sources do not settle.
ALLREQUIRES CONFIRMATION
EVERY LINE CARRIES ITS PUBLIC BASIS · UNCERTAINTY STAYS VISIBLE
- NO PREPARATION FOR THE FIT CHECK
- EXISTING STRATEGY STAYS PRIVATE
- NON-CONFIDENTIAL INPUT ONLY
- Independent by construction
- Falcr does not see the existing strategy.
- Inspectable work
- Sources, assumptions and uncertainty remain visible.
- Human release control
- AI supports research and structuring; a human reviews the released brief.
WHAT YOU PROVIDE
A short non-confidential device description, the intended use, and your target jurisdictions. Nothing else, and never the existing strategy.
From agreed non-confidential device facts and public regulatory sources, you receive a source-linked, human-reviewed Regulatory Pathway Brief to compare privately before product, evidence or submission work depends on the current assumptions.
We ran our own process blind against a device that was already cleared.
We took the intended use of a cleared AI triage device, stripped the identifying detail, and ran our process without knowing the answer. Then we compared what we produced against the public record.
FALCR, BUILT BLIND
THE PUBLIC RECORD
Match
FALCR, BUILT BLIND
The class and premarket route we expected for the stated intended use.
BUILT FROM INTENDED USE AND PUBLIC SOURCES
THE PUBLIC RECORD
The same class and the same route on the record.
PUBLIC CLEARANCE RECORD
Corrected
FALCR, BUILT BLIND
UNCERTAINTYRule 11 held open across Class IIa and Class IIb.
BUILT FROM INTENDED USE AND PUBLIC SOURCES
THE PUBLIC RECORD
The record settles at the lower of the two.
EU MDR ANNEX VIII, RULE 11
We were one step too cautious in Europe. That correction is now in the method.
INTERNAL METHOD CHECK AGAINST A PUBLIC CLEARANCE RECORD. NOT A CUSTOMER, NOT AN ENGAGEMENT, NOT AN ENDORSEMENT.
WHEN IT HELPS
Before one assumption shapes what you build, test or submit.
For teams that already have a regulatory strategy and are about to make a consequential commitment. Get a separate reference point without replacing your adviser or sharing their work.
01
Intended-use or indications wording is being fixed.
02
A classification, pathway or predicate is being relied upon.
03
Testing or evidence plans are about to be commissioned.
04
Market sequence or submission work is about to begin.
One independent brief. Five places where an early assumption can change the plan.
- 01
Likely classification and pathway by jurisdiction.
Public basis, assumptions and uncertainty.
- 02
Relevant public device records and limits of comparability.
Comparable records, indications language and comparability limits.
- 03
Evidence expectations that could affect testing or documentation.
Testing, evidence or documentation that may require planning or confirmation.
- 04
Intended-use and jurisdiction differences that could alter the pathway.
Wording and market differences that could change classification, pathway or evidence expectations.
- 05
Assumptions and questions still requiring formal confirmation.
What public sources cannot settle and where formal confirmation may be needed.
Falcr does not replace your existing strategy. It gives you an independent reference point for deciding which assumptions deserve another look.
REGULATORY PATHWAY BRIEF · SECTION 04
HUMAN-REVIEWED- 01
Intended-use wording drives the classification outcome.
EU MDRBASIS - 02
The stated output role, not the time-criticality of the finding, is often the operative question.
EU MDRASSUMPTION - 03
Held open across Class IIa and Class IIb where the output role is ambiguous.
EU MDRUNCERTAINTY - 04
Where the public record settles it, the brief says so and records the basis.
EU MDRBASIS
EVERY LINE CARRIES ITS PUBLIC BASIS · UNCERTAINTY STAYS VISIBLE
HOW IT WORKS
Independent by construction. Human-reviewed before release.
Falcr builds the second view without seeing the first. The work stays bounded, source-linked and explicit about assumptions and uncertainty.
01 CONFIRM FIT AND SCOPE
Identify the decision, jurisdictions and whether a bounded second opinion can be useful.
02 BUILD THE SEPARATE VIEW
Falcr works from agreed non-confidential input and public regulatory sources without seeing the first strategy.
03 REVIEW AND RELEASE
A human checks the sources, assumptions and uncertainty before the Regulatory Pathway Brief is released and discussed.
Every section states what it is built on, what is assumed and what is unresolved.
ANNOTATION LABELS
- BASIS
- What the section is built on, with the public source linked.
- ASSUMPTIONS
- Written down, not implied, so they can be challenged.
- UNCERTAINTY
- Where public information is incomplete, ambiguous or insufficient to support a firm conclusion.
- REQUIRES FORMAL CONFIRMATION
- What cannot be resolved from public sources and may require confirmation through the appropriate regulatory route.
A planning input: not a regulator’s decision.
What it is
- A bounded independent view built from agreed non-confidential input and public regulatory sources.
- A source-linked assessment of likely classification, pathway, relevant public device records and evidence expectations, with assumptions and uncertainty visible.
- A preliminary planning input for deciding what deserves another look or formal confirmation.
What it is not
- A determination or opinion of a regulator, notified body, conformity assessment body or authorised representative.
- Legal or formal regulatory advice.
- A dossier, submission, authority engagement or conformity assessment.
- A guarantee of classification, regulatory pathway, clearance, certification, registration, approval, evidence acceptance, timing or cost.
- A replacement for the manufacturer’s own legal and regulatory responsibilities.
Do not submit personal health information, patient data, confidential technical files, trade secrets or an existing regulatory strategy through the form.
Know whether a second opinion fits this decision in 20 minutes.
Bring the decision, target markets and what your team is about to commit. We’ll confirm whether a bounded independent review would be useful. No regulatory research or findings are generated on the call, and there is no obligation to continue after it.
- NOTHING TO PREPARE
- NON-CONFIDENTIAL INPUT ONLY
- NO OBLIGATION TO CONTINUE