Navi-vis presents PathClear

Evidence readiness for FDA SaMD submissions.

PathClear is a local-first regulatory evidence workspace that helps MedTech and SaMD teams map messy documents to FDA-oriented requirements, identify gaps, and prepare RA-review-ready draft packages with source links.

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Local-first Claim-to-source traceability FDA 510(k) SaMD focus

PathClear Evidence Coverage

Evidence coverage 72%

Critical gaps 3

Source-linked claims 28

Intended-use baseline Covered

Software documentation Partial

Predicate comparison Missing

Cybersecurity evidence Needs review

Claim: “The software analyzes patient signal data.”

Source: Software_Architecture.docx · page 3 · chunk 08

The product

PathClear turns evidence folders into regulatory readiness insight.

SaMD teams often have technical evidence scattered across IFUs, software architecture files, V&V reports, risk matrices, cybersecurity documents, clinical performance reports, and predicate materials. PathClear helps teams understand what is present, what is missing, and which claims are supported.

Requirement coverage

Maps uploaded evidence to FDA-oriented requirement slots for FDA 510(k) SaMD workflows.

Gap detection

Flags missing, partial, conflicting, or unsupported information before late-stage review.

Evidence graph

Connects source documents, evidence chunks, claims, requirements, gaps, and reviewer decisions.

Review-ready output

Exports evidence matrices, gap reports, draft sections, and audit logs for RA/QA review.

How it works

Simple upload on the surface. Requirement-driven evidence probing underneath.

PathClear does not ask a vague question like “is this FDA compliant?” It breaks FDA-oriented expectations into evidence slots, probes uploaded evidence, and stores findings with source references.

Drop evidence

Upload PDFs, DOCX, spreadsheets, images, or evidence folders into a local workspace.

Identify requirements

Select applicable FDA-oriented checks based on pathway, SaMD profile, AI/cyber flags, and predicate status.

Probe and map

Search each evidence slot and connect findings to exact source files, pages, tables, or chunks.

Highlight gaps

Show critical missing evidence, conflicts, unsupported claims, and remediation suggestions.

Review and lock

RA/QA users approve, edit, reject, or lock claims and requirement coverage.

Export package

Generate draft evidence matrices, gap reports, source-linked summaries, and audit logs.

For founders

Know what you have before you hire or submit.

See whether your evidence pack is covered, partial, missing, or conflicting before a formal submission sprint.

For RA operators

Reduce evidence chasing and review loops.

Move from manual source hunting to a claim-to-evidence map that supports review and gap closure.

For consultants

Turn low-margin assembly into structured analysis.

Use PathClear to create evidence inventories, gap reports, and draft packages faster for client review.

Regulatory boundaries by design

PathClear is advisory software.
RA/QA review is mandatory before export.
Outputs are draft / RA-review-ready, not FDA-approved.
Every material claim must be source-linked or gap-marked.

Trust model

Built for sensitive evidence and human review.

PathClear is designed as a local-first desktop workflow so sensitive evidence can remain under customer control. The app records source references, reviewer decisions, and audit events to help teams prepare reviewable regulatory evidence packages.

Local-first workspace Source-bound claims Reviewer audit trail No autonomous regulatory decisions

Pilot study

Evaluate PathClear on one scoped SaMD evidence folder.

PathClear is best evaluated through a focused pilot study with measurable outputs: requirement coverage, source-linked claims, gap report, reviewer workflow, and a draft evidence package.

Evidence Readiness Scan

Inventory available evidence, classify uploaded documents, and identify the highest-priority missing or conflicting items.

Discuss pilot scope →

FDA 510(k) SaMD Pilot

Run one scoped workflow: upload evidence, map requirement coverage, flag gaps, and prepare RA-review-ready outputs with source links.

Request pilot study

Follow-on Workflow

Extend the pilot into repeat submissions, software modifications, consultant workflows, or additional device evidence packages.

Plan next workflow →

Navi-vis.tech

Evaluate PathClear with your SaMD evidence pack.

Request a pilot or share your use case. We will scope the workflow around evidence readiness, requirement coverage, and RA/QA review.