Regulatory Intelligence for MedTech

Accelerate Time to Clearance and Approvals With Unparalleled Insights and Analytics

The Basil Intel platform sets a new industry standard for search and discovery – when data mining the regulatory landscape to shape product development strategies, optimize submissions, and influence innovation with unprecedented speed. Transform weeks of research into minutes for actionable insights across all application types, predicates, guidance documents, product codes, UDI filings, regulations, clinical trials, and more.

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Regulatory Analytics, Data & Insights

Advanced Regulatory Intelligence

Gain new insights across all related products and technologies for regulatory discovery and strategy.

Explore all related 510(k)s, PMAs, regulations, guidance, product codes, clinical trials, and more in one comprehensive search to inform due diligence and competitive intelligence.

Identify competitor regulatory strategies, including predicate selection, product code categorization, and clinical requirements, for submission planning and innovation.

State-Of-The-Art Big Data Architecture

Access data across dozens of MedTech databases, including application summaries, product codes, regulations, guidances, clinical trials, and more.

Leverage AI-powered indexing, cross referencing, and error correction for the most accurate data.

All datasets are refreshed daily and presented with the latest version for accurate and actionable insights.

Full-Text Natural Language Search

Search across all records, files, documents, and categories at once.

Navigate and analyze 510(k)s, PMAs, product codes, regulations, recalls, adverse events, and more with ease.

Comprehensive data and search efficiency enables regulatory exploration and discovery that was not previously possible.

Unmatched, Unique Capabilities

Research predicate relationships per device through the industry's only dynamic ecosystem map – and avoid predicate creep.

Review time-to-approval statistics for applications and benchmarking – facet by product code, application type, review panel, year filed, and more to ensure the fastest route to market.

Access instant quality trends to assess strategic risks.

Case Study: Accelerating Submission Strategy

A MedTech company preparing a 510(k) submission needed to validate whether stronger predicates or alternative product codes would improve approval probability. Using Basil’s device ecosystem map, the team identified two overlooked reference devices. The revised strategy reduced projected review time and strengthened the substantial equivalence argument before submission.

"Basil Systems is simply revolutionary. They solved the long-standing problems with FDA data. We use it every day for regulatory research and strategy."

VP, Regulatory Strategy

Fortune 500 MedTech

Basil Regulatory Intelligence delivers clarity, speed, and confidence.

Unified Data

Discover all application types, guidance documents, product codes, UDI filings, regulations, clinical trials, and more.
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Rapid Insights

Transform regulatory research from manual search into structured intelligence to reduce risk and accelerate timelines.
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Market Success

Leverage the proven data and analytics MedTech leaders trust to achieve faster approvals and product differentiation.

< 1-Hour Implementation

Get your team operational immediately with minimal IT overhead—no multi-month deployment cycles.
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Protect Your Launch Curve

Every day of delay costs hundreds of thousands in lost revenue. Basil ensures you respond before competitors gain ground.
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