KnowledgeNET

KnowledgeNET

Sarjen Systems
+
+

Related Products

  • RegDesk
    19 Ratings
    Visit Website
  • Maintenance Care
    293 Ratings
    Visit Website
  • Jotform
    8,651 Ratings
    Visit Website
  • Hyperproof
    350 Ratings
    Visit Website
  • DropTrack
    191 Ratings
    Visit Website
  • Nasdaq Metrio
    14 Ratings
    Visit Website
  • XpertCoding
    42 Ratings
    Visit Website
  • LM-Kit.NET
    29 Ratings
    Visit Website
  • Monk
    7 Ratings
    Visit Website
  • Captain Compliance
    287 Ratings
    Visit Website

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

Sarjen's global dossier publishing software is a platform designed to simplify and automate the management and submission of regulatory dossiers. It streamlines the regulatory submission process by automating region-specific and product-specific workflows, which enhances consistency, efficiency, and accuracy. This automation helps to accelerate the creation, validation, and submission of dossiers, reducing manual errors and compliance issues. The solution is built to improve operational efficiency, maintain data consistency, and ensure documentation is audit-ready. By doing so, it saves time and facilitates faster regulatory approvals, ultimately helping to ensure submissions are compliant with various global requirements.

Platforms Supported

Windows Supported
Mac Not Supported
Linux Not Supported
Cloud Supported
On-Premises Not Supported
iPhone Not Supported
iPad Not Supported
Android Not Supported
Chromebook Not Supported

Platforms Supported

Windows Supported
Mac Not Supported
Linux Not Supported
Cloud Supported
On-Premises Supported
iPhone Not Supported
iPad Not Supported
Android Not Supported
Chromebook Not Supported

Audience

Medical companies, regulatory consultants

Audience

Biotech companies

Support

Phone Support Supported
24/7 Live Support Supported
Online Not Supported

Support

Phone Support Supported
24/7 Live Support Supported
Online Supported

API

Offers API Not Supported

API

Offers API Not Supported

Screenshots and Videos

Screenshots and Videos

No images available

Pricing

Credit-based system
Free Version Not Supported
Free Trial Not Supported

Pricing

$200
Free Version Not Supported
Free Trial Not Supported

Reviews/Ratings

Overall 5.0 / 5
ease 5.0 / 5
features 5.0 / 5
design 5.0 / 5
support 3.0 / 5

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software

Pros & Cons from Real Users

Pros

  • The reason for the 5 stars is the fact that the services solved a great pain. I think it is the right use of AI; there is no question to me AI can read predicates and classification docs in minutes what would take a human months

Cons

  • It is a do it yourself and you still have to take final decisions on classification and predicate. More guidance would be appreciated

Training

Documentation Supported
Webinars Not Supported
Live Online Supported
In Person Not Supported

Training

Documentation Supported
Webinars Supported
Live Online Supported
In Person Supported

Company Information

Cruxi
Founded: 2024
United States
cruxi.ai

Company Information

Sarjen Systems
Founded: 1998
India
www.sarjen.com

Alternatives

RAMS

RAMS

Emergo by UL

Alternatives

ViSU

ViSU

DDi
waiting

waiting

Python Software Foundation
Labrynth AI

Labrynth AI

Labrynth
RIMTrack

RIMTrack

WinWire Technologies

Categories

Medical Affairs Supported

Categories

Integrations

No info available.

Integrations

No info available.
Claim Cruxi and update features and information
Claim Cruxi and update features and information
Claim KnowledgeNET and update features and information
Claim KnowledgeNET and update features and information