ArgusQuery.ai
AI Document Creator
Collate complex FDA FILINGS (510K, De-Novo, PMA) in minutes!
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Drafting complex regulatory documents requires significant manual effort, taking days or months to complete. AI Doc Creator automates the creation of documents, instantly compiling, formatting, and phrasing content in minutes.​
Compiling Documents for FDA Filings is not easy and takes time.
Typical time for document assembly
510K: If you have all your data (e.g., test results, safety and performance data, labeling, and device descriptions), assembling the submission package typically takes 2-4 weeks.
PMA: with all the required data (e.g., clinical data, preclinical studies, device testing, and labeling), organizing the submission is a detailed process. This can take 2-6 months.
Step 1.​ Upload Data. Select Template.
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Step 2. Indicate Product name and Predicate names and any other specific instructions.
Step 3. ​Hit 'Generate
Step 4. Edit, Download, and Share
Features
Functionality You Will Love
Customizable Templates. Generate anything.
Create any document or content. Simply include the topics, related data, instructions and generate.
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Guardrails
Build compliance guardrails needed for your industry. HIPPA, Identifiers, Personal Information etc.
Edit with AI
Edit further with AI. Simply say how you want it written and AI will do your bidding.
Accuracy
High density embeddings and RAG architecture ensures high accuracy.
Case Study - 510K FDA Filing - Medical Device Manufacturer
A fast growing medium sized medical device manufacturer had tight timelines to submit 510K Applications for FDA approval. Finding, collating, editing and consolidating information was taking time and regulatory and quality resources were stretched.
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AI Document creator was customized to build 510 K Filing using product information, predicate information, test data and other specific manufacturing and labeling information
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Now Regulatory personnel can generate entire 510 K filings simply by:
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Giving prompts as simple as "Generate a 510 K filing for {product name} and use {predicate 1}, and {predicate 2}
This solution dramatically amplified the Regulatory team's ability to generate and file 510K filings and meeting key deadlines.
Regulatory Manager
"Giving prompts as simple as "Generate a 510 K filing for {product name} and use {predicate 1}, and {predicate 2} .....Now I can create the entire filing in minutes."
CEO
” The Argus AI Doc Creator for FDA 510K Filing helped us submit in record time.”
ArgusQuery.ai