Cut FDA Audit Prep Time by 90%
Search across IFUs, recalls, FSNs, and MAUDE reports—including tables, diagrams, and risk matrices—with 92% accuracy. Built for RA, QA, and PMS teams.
Outperforms GPT-4o, Gemini, and Claude on regulatory documents.
Benchmarked: IFUs, FDA recalls, FSNs, MAUDE reports, FMEAs, ISO 14971 risk files
Trusted by Regulatory Affairs, Quality Systems, and Post-Market Surveillance teams navigating FDA audits, EU MDR compliance, and global vigilance workloads.
Interactive retriever playground
Launch Full RetrieverMultimodal Extraction
Tables, diagrams, schematics, FMEA matrices, and warning symbols with structural accuracy.
Diagram-Aware Search
Find assembly drawings, flowcharts, and schematics by description—not filename.
Multi-Hop Retrieval
Link recalls ↔ IFUs ↔ MAUDE events ↔ CAPAs across thousands of documents.
See It In Action
From messy IFU PDF to structured, queryable data in seconds.
// Embedded warning section...
WARNING
Do not operate device if battery pack shows signs of thermal degradation or swelling.
// Assembly diagram (figure 3.12)...
// Multi-column layout, headers span rows, no context...
{"device_name": "X200 Infusion Pump","doc_type": "IFU","manufacturer": "MedTech Inc.","warnings": [{"text": "Do not operate if battery pack shows thermal degradation","severity": "critical","source": "p.44, section 5.2"}],"diagrams": [{"type": "assembly","caption": "Cassette assembly steps","source": "figure 3.12, p.28","searchable": true}],"related_recalls": ["FDA-2023-1154"],"similar_adverse_events": ["MDR-2024-00123"]}
Capability Benchmarks
Tested on 500+ IFUs, FSNs, recalls, and 5,000 MAUDE reports. These benchmarks measure regulatory-specific capabilities, not general intelligence.
Table Extraction
Cell-level accuracy extracting FMEA matrices, specification tables, and risk matrices with merged cells and multi-level headers.
Diagram Retrieval
Improvement over text-only search when retrieving assembly drawings, flowcharts, schematics, and labeled component diagrams.
Retrieval Precision@3
Percentage of queries where the correct IFU section, recall, or MAUDE report appears in the top 3 results.
These benchmarks test specific regulatory document capabilities. GPT-4 is a better general assistant—we're a better regulatory document parser. Different tools for different jobs.
How It Works
Two pipelines working together to transform regulatory documents into answers
Extraction Pipeline
Retrieval Pipeline
Why Generic LLMs Fail at Regulatory Documents
GPT-4, Claude, and Gemini are great general assistants—but regulated documentation needs specialized extraction.
| Problem | Generic LLMs | Mixpeek |
|---|---|---|
| Diagram/figure search | Cannot retrieve or search diagrams by content | Full diagram extraction + CLIP hybrid retrieval |
| Table structure | Breaks row/column relationships in FMEA tables | 92.4% cell accuracy with source attribution |
| Cross-document linking | No memory across IFUs, recalls, MAUDE reports | Multi-hop retrieval linking related documents |
| Version control | Confuses older vs. newer IFU versions | Version-aware metadata + section diff |
| Regulatory language | Literal keyword matching, misses synonyms | Semantic, regulatory-domain search |
| Risk matrices | Fails on FMEA severity/probability tables | Embedded risk tables fully queryable |
Share with Your Team
Download the 2-page executive brief with ROI model, time savings by activity, and implementation timeline.
Download PDFUse Cases
Transform how your RA, QA, and PMS teams work with regulatory documentation
FDA Audit Preparation
Retrieve all relevant IFU sections, test reports, risk controls, and supporting evidence with a single query. 3-5 days → 2-4 hours.
CAPA Investigations
Find similar incidents, related complaints, risk file content, and design documentation instantly across your QMS.
Adverse Event Correlation
Identify similar MAUDE events, complaints, and recalls using semantic similarity—not keywords. 91% Precision@3.
Field Safety Notice Development
Retrieve all related IFU warnings, historical FSNs, and regulatory precedents when drafting new safety communications.
Supplier Quality
Surface recurring supplier-related quality issues through cross-document pattern matching across CAPAs and NCRs.
Risk Management Files
Search FMEA tables, risk matrices, and ISO 14971 documentation with full semantic understanding and cell-level accuracy.
Download the 2-page brief with time savings for each use case.
90-Second Overview
Product Demo Video
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See how Mixpeek transforms medical device regulatory document intelligence
Developer Quickstart
Get started in minutes with our simple API
from mixpeek import Mixpeekclient = Mixpeek(api_key="YOUR_API_KEY")# Index an IFU documentresponse = client.collections.medical_device.index(document_id="ifu-x200-pump-v2",url="https://example.com/ifu.pdf",doc_type="ifu")# Query regulatory documentsresults = client.collections.medical_device.query(query="battery warnings infusion pump",doc_types=["ifu", "recall", "fsn"])
Ready to Deploy
Includes ingestion, extraction, multi-hop retrieval, and flexible deployment options. VPC and on-prem available.
Flexible pricing that scales with your document volume and team size. Custom enterprise plans available for validated environments and dedicated support.
Frequently Asked Questions
Common questions from RA, QA, and Post-Market Surveillance teams.
Ready to Transform Your Regulatory Documentation Workflow?
Start searching across IFUs, recalls, FSNs, and MAUDE reports in minutes—with diagrams, tables, and cross-document linking.