Cruxi

Cruxi

5.0 out of 5 stars
ProcEdge RIMS

ProcEdge RIMS

Sarjen Systems Pvt Ltd
Cruxi ProcEdge RIMS

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Cruxi:

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.
ProcEdge RIMS:

About

ProcEdge RIMS is a centralized regulatory information management system designed to streamline global product registration and post-registration activities. It replaces error-prone manual methods like Excel with a unified platform that offers real-time access to product data across departments. The system tracks submissions, renewals, and regulatory correspondence with configurable workflows and automated reminders to ensure compliance with varying international regulations. It supports industry standards such as IDMP and meets GxP, GDPR, and 21 CFR Part 11 compliance requirements. By consolidating regulatory data and workflows, ProcEdge RIMS helps companies reduce operational costs and speed up time to market. Its robust query management and audit trail features improve submission quality and regulatory responsiveness.
Cruxi:

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
ProcEdge RIMS:

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
Cruxi:

Audience

Medical companies, regulatory consultants
ProcEdge RIMS:

Audience

Regulatory affairs professionals and compliance teams in pharmaceutical, biotech, and healthcare industries seeking a centralized, compliant platform to manage global product registration and regulatory information efficiently
Cruxi:

Support

Phone Support Supported
24/7 Live Support Supported
Online Not Supported
ProcEdge RIMS:

Support

Phone Support Supported
24/7 Live Support Supported
Online Supported
Cruxi:

API

Offers API Not Supported
ProcEdge RIMS:

API

Offers API Not Supported
Cruxi:

Screenshots and Videos

ProcEdge RIMS:

Screenshots and Videos

No images available
Cruxi:

Pricing

Credit-based system
Free Version Not Supported
Free Trial Not Supported
ProcEdge RIMS:

Pricing

$300
Free Version Not Supported
Free Trial Not Supported
Cruxi:

Reviews/Ratings

Overall 5.0 / 5
ease 5.0 / 5
features 5.0 / 5
design 5.0 / 5
support 3.0 / 5
ProcEdge RIMS:

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
Cruxi:

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
Cruxi:

Training

Documentation Supported
Webinars Not Supported
Live Online Supported
In Person Not Supported
ProcEdge RIMS:

Training

Documentation Supported
Webinars Supported
Live Online Supported
In Person Supported
Cruxi:

Company Information

Cruxi
Founded: 2024
United States
cruxi.ai
ProcEdge RIMS:

Company Information

Sarjen Systems Pvt Ltd
Founded: 1998
India
rims.sarjen.com
Cruxi:

Alternatives

RAMS

RAMS

Emergo by UL
ProcEdge RIMS:

Alternatives

Cruxi:
ProcEdge RIMS:
Cruxi:
ProcEdge RIMS:
LICENSALE

LICENSALE

Arazy Group
Cruxi:
waiting

waiting

Python Software Foundation
ProcEdge RIMS:
Cruxi:
ProcEdge RIMS:
ViSU

ViSU

DDi
Cruxi:

Categories

Medical Affairs Supported
ProcEdge RIMS:

Categories

Cruxi:

Integrations

No info available.
ProcEdge RIMS:

Integrations

No info available.
Cruxi:
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ProcEdge RIMS:
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