Quality & Safety Intelligence for MedTech

Unleash Post-Market Surveillance and Safety Insights

The Basil Intel platform delivers immediate insights to drive mission-critical quality, safety, R&D, product strategy, and marketing efforts. Assess trends and analytics on the market performance of manufacturers and products with the post-market surveillance solution trusted by global MedTech leaders. Leverage Basil's AI-enabled, comprehensive dataset to discover hidden correlations and predictive patterns across adverse events and internal complaints to identify risk earlier, protect revenue, and improve patient safety. Standardize your post-market compliance by benchmarking IMDRF classifications against industry peers, ensuring consistent reporting that minimizes the risk of FDA scrutiny. Satisfy European reporting needs to prove safety across brands and export full CER/PSUR data tables effortlessly, saving months of effort.

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Quality & Safety Analytics, Data & Insights

Advanced Post-Market Surveillance

Access comprehensive reports and powerful trend visualizations of recalls, adverse events, warning letters, citations, reported patient problems, demographics, and more.

Search post-market events across the MedTech industry by review panels, manufacturers, product categories, brands, or devices.

Stay ahead of the market with real-time email alerts as soon as new recalls, adverse events, or other watchlist triggers occur.

AI-Enabled Safety Insights

Recall Signatures: AI scans millions of AE narratives for events related to a recall, accelerating analysis with a traceable AE list and confidence scoring.

Safety Signals: Analyze competitor AEs by product code and prioritize internal complaints for a risk-ranked signal landscape with AE event clusters and emerging signals by outcome.

Inform product and quality strategies with highly accurate data that delivers reliable insights – with no AI hallucinations.

Optimized IMDRF Analysis

Analyze competitive FDA complaint narratives to illuminate the IMDRF codes selected for similar events by peers across the MedTech industry.

Device-to-industry benchmarking allows teams to compare with competitor precedents, avoid unnecessary FDA flags, and prevent over- or under-reporting.

Know how competitors classify identical failure modes versus coding in a vacuum to avoid FDA friction.

CER/PSUR Comparative Data Tables

Access comprehensive comparative quality data across any desired product brands by device problem, patient problem, and recall class/type.

Download full details and completed charts of all event records for Euro-MDR/IVDR submissions, EUDAMED compliance, and fulfilling CE mark requirements.

Minimize time spent on data collection and analysis from weeks to minutes for internal and external reporting.

Comprehensive, Accurate Data for Actionable Insights

Analyze broad industry data at once in a single interface.

Identify trends, spot potential issues ahead of time, and perform comprehensive comparisons.

Visualize the latest information with automatically updated datasets and alerts for easy-to-track safety notices and early trend detection.

Tailor datasets for specialized monitoring and analysis with unlimited data exports and instant, presentation-ready charts.

Case Study: Fast, Efficient Post-Market Analytics

A global MedTech manufacturer needed to streamline post-market surveillance across multiple product lines while preparing CER and PSUR submissions. Using Basil, the Quality and Safety teams built comprehensive comparative analysis tables from global adverse event data, recalls, and regulatory actions – all within a single interface. What previously required more than seven weeks of manual searching, table creation, and publishing was reduced to under 20 minutes, delivering a 98% efficiency gain. By continuously updating datasets and triggering alerts for new changes, the team saved tens of thousands of dollars per submission while accelerating regulatory acceptance without comments.

"Basil transformed our post-market reporting from manual grind to strategic advantage."

VP, Quality & Post-Market Surveillance

Top 5 MedTech

Basil Quality & Safety Intelligence delivers visibility, efficiency, and strategic insights.

Post-Market Intel

Spot problems and identify opportunities across recalls, adverse events, warning letters, citations, reported patient problems, and more.
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Safety Signals

Leverage non-hallucinating AI to analyze millions of AE narratives and uncover issues that may drive a recall, ensuring quality and protecting patients.
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CER/PSUR & IMDRF

Rapidly create CER/PSUR tables for MDR/IVDR submissions. Benchmark competitor IMDRF codes to prevent FDA pushback.

< 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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