AI TOOL PROFILE
Cruxi: AI-Powered Regulatory Submissions Platform
- Legal
- Compliance Management
- Medical device startups
- In-house regulatory affairs teams
- Regulatory consultants
- Healthcare companies seeking US market access
Pricing
Launch pricing is $100 for the full workflow or $20 per individual service, with a 90% discount for three months available through May 21, 2026.
At a glance
- Best for
- Medical device startups, In-house regulatory affairs teams, Regulatory consultants, Healthcare companies seeking US market access
- Key use cases
- FDA 510(k) Preparation, De Novo Classification Requests, Regulatory Assessment, Global Market Entry
- Official website
- Visit Cruxi official website
How AI is used
Cruxi is a regulatory submissions platform designed for medical device companies navigating FDA and global market entry. It uses specialized AI agents to support the initial classification and drafting process, which can then be reviewed by internal teams or external consultants.
The tool is designed for medical device manufacturers and regulatory professionals preparing 510(k), De Novo, or PMA submissions. It supports the creation of eSTAR-aligned content and provides a directory of consultants for human validation of the output.
Cruxi supports research tasks such as scanning regulations to identify product codes and matching devices against predicate databases to establish substantial equivalence. It also includes tools for evidence planning and submission package generation.
Buyers should confirm if the AI-generated drafts meet their specific technical requirements and should note that the platform is an assistive tool; a human regulatory lead remains responsible for the final submission and strategy.
Key Features
AI-Powered Classification
Identifies product codes, regulation numbers, and classification pathways by analyzing device descriptions and intended use.
Predicate Device Identification
Searches and scores potential predicate devices based on technological characteristics and intended use to support substantial equivalence claims.
eSTAR Editor and Drafting
Generates and edits content for the 18 eSTAR sections, with claims linked to regulatory sources to support traceability.
Automated RTA Checks
Validates submission completeness and format compliance to help reduce the risk of Refuse-to-Accept (RTA) letters.
Evidence Planning
Maps required evidence, including testing and standards, and supports the organization of supporting documentation.
Consultant Directory
Provides access to a network of vetted FDA consultants for expert review and final sign-off of submission packages.
Use Cases
FDA 510(k) Preparation
Using AI agents to identify predicates and draft substantial equivalence sections of a 510(k) submission.
De Novo Classification Requests
Supporting the documentation process for novel, low-to-moderate risk devices using eSTAR templates.
Regulatory Assessment
Analyzing a device against 18 eSTAR sections to identify necessary evidence and testing requirements.
Global Market Entry
Preparing technical documentation for EU MDR, UKCA, and Health Canada MDL submissions.
FAQ
What does Cruxi do for FDA 510(k) submissions?
- Cruxi uses AI agents to help with device classification, identifying predicate devices, mapping evidence requirements, and drafting content for eSTAR submission sections.
Can Cruxi replace a regulatory consultant?
- No, it is designed to assist with drafting and research. Human experts are still required for strategy, final decisions, and signing off on submissions.
How does Cruxi handle AI hallucinations?
- The platform uses a structured FDA regulatory database and retrieval techniques to ensure claims are traceable to verified sources, regulations, or uploaded documents.
Is there a free trial or assessment?
- Cruxi offers a free 510(k) device assessment that provides regulatory insights without requiring a sign-up.
Source category: Legal
Source subcategory: Compliance Management
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