Cruxi Regulatory
Cruxi Regulatory
Cruxi is a vertical AI platform built specifically for medical device regulatory teams. It ingests FDA regulations, guidance, product codes, standards, MAUDE events, recalls, and prior 510(k) data to power agentic workflows for 510(k), De Novo, and eSTAR. Users can run rapid device classification, compare predicates, plan evidence, and generate fully cited, eSTAR-aligned content for each subsection of the submission. Cruxi offers both full-submission workflows and focused micro-services (e.g., classification, predicate analysis, specific section drafting), making it ideal for early-stage startups, in-house regulatory teams, and consultants who want to deliver high-quality submissions with less manual work and fewer surprises from FDA.
Buyer Snapshot
Best for
- Early-stage startups needing regulatory support
- In-house regulatory teams seeking efficiency
- Consultants aiming to reduce manual workload
How engagement typically works
- Full-submission workflows
- Focused micro-services
Typical deliverables
- Device classification reports
- Predicate comparison analyses
- Evidence planning documentation
- Drafted submission content (eSTAR-aligned)
Good to know
- Best when leveraging AI for structured regulatory tasks.
Status:
claimed
Services & Capabilities
FDA 510(k) Submission Services
Services Offered:
Device Classification Support, Special 510(k) Support, 510(k) RTA Remediation / Refuse-to-Accept Fix, PMA Strategy & Support, Labeling Review for Submission (510(k)/De Novo/PMA), 510(k) eSTAR Preparation, Abbreviated 510(k) Support, De Novo Strategy & Authoring, FDA Meeting Support (Q-Sub / Type C), Regulatory Pathway Assessment, 510(k) Strategy & Authoring, Traditional 510(k) Support, Predicate Research & Substantial Equivalence Strategy, Submission Project Management (end-to-end)
Pathways Supported:
Traditional 510(k), Special 510(k), PMA, Pre-Sub / Q-Sub, Abbreviated 510(k)
Device Types Supported:
Medical device, Combination product
Supports Estar:
Yes
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Supports Labeling Review:
Yes
Provides Submission Project Management:
Yes
Years Experience:
5
Num510k Submitted:
140
Ex FDA:
No
Ex Notified Body:
Yes
Ex Big Medtech:
No
Accepting New Clients:
No
Typical Lead Time Weeks:
2
Response Time Hours:
8
Additional 510k_submission_services Details
Services Offered
510(k) strategy/authoring, eSTAR preparation, predicate research, De Novo submissions, focused micro-services (classification, predicate analysis, section drafting).
Pathways Supported
510(k), De Novo, eSTAR.
Supports Estar
true
Supports Rta Remediation
false
Supports Predicate Research
true
Supports Labeling Review
false
Provides Submission Project Management
false
