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Fragmented information
Regulations, guidance, product classifications, and historical FDA decisions are spread across different sources and formats.
An early-stage regulatory intelligence initiative
Regulatory clarity.
Earlier.
Promising medical technologies should move forward with better evidence—not get held back by preventable regulatory missteps.
Regavise is developing an expert-guided AI platform that connects authoritative FDA sources with device-specific regulatory planning, from early development to post-market compliance.
America’s Startup competition · 2026 entry Public concept & implementation preview
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DESIGN PREVIEWRegulatory workspace510(k) pathway · interface concept
SAMPLE DEVICE PROFILE•••
Radiotherapy treatment planning software
Illustrative technology category · Intended use and classification require device-specific review
PROPOSED REGULATORY WORKFLOW
Establish device contextIntended use, technology, development stage
01Retrieve FDA evidenceClassification, guidance, clearance records
02Map gaps & next stepsEvidence needs and regulatory considerations
03◆Example authoritative reference
FDA product code MUJ · Radiotherapy treatment planning system
View official FDA classification Illustrative workflow, not an AI-generated regulatory assessment
DESIGNED FOR THE DEVICE DEVELOPMENT LIFECYCLE01 / 05
THE CHALLENGE
The costliest regulatory mistake can happen long before submission.
For early-stage medical-device teams, regulatory strategy begins with intended use, design decisions, testing plans, evidence needs, and quality systems—not with the final submission.
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Decisions made too late
Gaps discovered late in development may require additional tests, redesign, or repeated studies—consuming time and capital.
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?✓
Answers without judgment
Generic AI can summarize information. Regulatory work also demands source traceability, device context, uncertainty, and expert oversight.
THE OPPORTUNITY
Make regulatory knowledge more actionable earlier—especially for innovators who cannot maintain large in-house regulatory teams.
Our proposed approach THE REGAVISE APPROACH
From regulatory information to regulatory direction.
Our vision combines authoritative sources, device-specific workflows, and human regulatory expertise. The workflow below describes planned product capabilities—not currently deployed advisory functionality.
Describe the device
Capture intended use, underlying technology, development stage, and practical constraints.
DEVICE CONTEXT
Ground in FDA sources
Connect to classification information, 510(k) records, applicable regulations, and FDA guidance.
TRACEABLE EVIDENCE
Plan & check
Propose pathway considerations, evidence needs, development checkpoints, and document consistency checks.
ACTIONABLE WORKFLOWS
Keep the expert in the loop
Surface limitations, highlight uncertainty, and route consequential judgments for human review.
HUMAN OVERSIGHT
Our design principle: an answer is only as useful as the evidence and reasoning behind it.
EXPERT-GUIDED. SOURCE-LINKED. CONTEXT-AWARE. IMPLEMENTATION PREVIEW · LIVE PUBLIC DATA
Explore real FDA
510(k) records.
This small working component retrieves public 510(k) clearance records directly from the openFDA API. It demonstrates live source connectivity—not an operational RAG engine or regulatory advisor.
Live API integrationPublic FDA data · No Regavise accounts required
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Ready to explore public records.Select a sample product code and search. Live results will appear here.
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What is implemented: a browser-based lookup that requests and displays live openFDA 510(k) records and, when available, device classification metadata. What is not implemented here: document-level RAG, automated predicate selection, regulatory roadmaps, and AI-generated advice. Those are research and product-development objectives.
WHY REGAVISE
Designed around decisions, not just documents.
Search is necessary, but not sufficient. Medical-device teams need to know which questions to ask, what evidence to generate, and when a conclusion demands human judgment.
See what we're buildingEarlier in the lifecycle
Help teams spot regulatory gaps before expensive downstream changes.
Device- and indication-specific
Plan for the particular device, intended use, and development context.
Traceable by design
Connect regulatory claims to official sources and make uncertainty visible.
Expert-guided
Preserve professional oversight for nuanced or consequential judgments.
DEVELOPMENT ROADMAP
A focused start.
A broader vision.
The first technical priority is a 510(k)-focused, source-grounded retrieval system. Later stages depend on testing, regulatory validation, and development milestones.
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AVAILABLE ON THIS SITE
Public FDA evidence explorer
Working browser-side connection to openFDA 510(k) clearance and device classification data. A narrow but demonstrable first integration.
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RESEARCH OBJECTIVE
510(k) retrieval-augmented generation pilot
Index selected FDA sources, compare embeddings and hybrid retrieval, test citation validity, and benchmark regulatory questions. Targeted undergraduate research; not presented as completed.
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PLANNED
Expert-guided regulatory workflows
Connect device context to source-linked development plans, evidence needs, documentation checks, and human review.
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FUTURE DIRECTION
Beyond 510(k)
Evaluate expansion to De Novo, HDE, PMA, and wider lifecycle support after the initial approach is validated.
FOUNDING PERSPECTIVE
Built at the intersection of engineering and regulatory judgment.
Regavise brings together biomedical engineering, technology commercialization, and regulatory experience to address a practical problem for innovators.
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FOUNDER
Nathan Yap
Biomedical engineering and finance · Washington University in St. Louis
FDA
REGULATORY EXPERTISE
Former FDA CDRH Branch Chief
Experience spanning premarket submissions, post-market compliance, and regulatory submission-data architecture.
An independent early-stage initiative. Not affiliated with or endorsed by the U.S. FDA.
RESEARCH FOUNDATION
Grounded in authoritative sources.
Examples of official FDA resources relevant to the proposed first phase.
01Premarket Notification 510(k)FDA's explanation of the pathway and substantial equivalence↗02510(k) clearance databasePublic device clearance and submission information↗03Product classification databaseDevice product codes, classifications, and regulatory context↗04openFDA Device 510(k) APIPublic structured clearance records used in the explorer↗
THE REGAVISE VISIONLess avoidable rework.
Less avoidable rework.
More promising technologies moving forward.
We are starting with FDA 510(k) intelligence—and building toward more informed regulatory decisions across the medical-device lifecycle.
Explore the live FDA lookup