Related Products
|
||||||
About
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.
|
About
RQM+ is a global medical technology service provider focused on accelerating compliance and market success. Through our unparalleled expertise and industry knowledge, we deliver specialized solutions and expedite the journey along the full product lifecycle for medical technology companies, from concept to commercialization to post-market. Our portfolio of services enables the delivery of end-to-end solutions across the complete medical device product lifecycle. RQM+’s quality assurance engineers review material lists, set up suppliers, and support the design change process. RQM+’s design quality engineers help support packaging, sterility, biocompatibility, and device testing that may be needed. RQM+’s regulatory affairs consultants provide guidance and help with submissions to the FDA, notified bodies, or other government agencies. We use our extensive experience with the latest reimbursement requirements and value-based compensation models.
|
|||||
Platforms Supported
Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook
|
Platforms Supported
Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook
|
|||||
Audience
Medical companies, regulatory consultants
|
Audience
Medical technology companies in search of a solution to manage their compliance and regulation processes
|
|||||
Support
Phone Support
24/7 Live Support
Online
|
Support
Phone Support
24/7 Live Support
Online
|
|||||
API
Offers API
|
API
Offers API
|
|||||
Screenshots and Videos |
Screenshots and Videos |
|||||
Pricing
Credit-based system
Free Version
Free Trial
|
Pricing
No information available.
Free Version
Free Trial
|
|||||
Reviews/
|
Reviews/
|
|||||
Training
Documentation
Webinars
Live Online
In Person
|
Training
Documentation
Webinars
Live Online
In Person
|
|||||
Company InformationCruxi
Founded: 2024
United States
cruxi.ai
|
Company InformationRQM+
United States
www.rqmplus.com
|
|||||
Alternatives |
Alternatives |
|||||
|
|
||||||
|
|
|
|||||
|
|
||||||
Categories |
Categories |
|||||
Integrations
No info available.
|
Integrations
No info available.
|
|||||
|
|
|