Innovatum (eLabeling / eIFU + ePIC)
Cruxi Inc.
Cruxi offers an AI-powered platform simplifying medical device regulatory submissions to the FDA and global markets. They provide 14 services from device classification to final submission packages.
Cruxi provides an AI-powered platform designed to streamline medical device regulatory submissions. Their services cover the entire process, from initial device classification to final submission packages for FDA and global markets. They offer 14 distinct regulatory services, including FDA 510(k), De Novo Classification Requests (eSTAR), Q-Submissions (Pre-Sub), and IDE Submissions. The platform leverages intelligent automation, automated compliance checks, and expert guidance to simplify complex regulatory pathways. Cruxi aims to be a comprehensive solution for all regulatory needs, utilizing AI workflows to enhance efficiency and compliance for medical device manufacturers.
About
**Who they are**
Innovatum (eLabeling / eIFU + ePIC) provides enterprise labeling and regulatory data management solutions, with a focus on FDA-regulated industries including pharmaceuticals, medical devices, and biotechnology.
**Expertise & scope**
* Offers the ROBAR Enterprise Label Management System.
* Manages regulatory data as a RIMS and integrates with PIMS data for label printing.
* Facilitates the bidirectional process of regulatory data submissions and approvals using technologies like HL7.
* Provides solutions that can be deployed on-premises, hosted, or as SaaS, with hosted and SaaS options being single-tenant for enhanced security.
* Delivers direct customer support and project management for the ROBAR system, with all enhancements included as part of maintenance and upgrades.
**Reputation / proof points**
* ISO 9001:2015 Certified
Innovatum (eLabeling / eIFU + ePIC) provides enterprise labeling and regulatory data management solutions, with a focus on FDA-regulated industries including pharmaceuticals, medical devices, and biotechnology.
**Expertise & scope**
* Offers the ROBAR Enterprise Label Management System.
* Manages regulatory data as a RIMS and integrates with PIMS data for label printing.
* Facilitates the bidirectional process of regulatory data submissions and approvals using technologies like HL7.
* Provides solutions that can be deployed on-premises, hosted, or as SaaS, with hosted and SaaS options being single-tenant for enhanced security.
* Delivers direct customer support and project management for the ROBAR system, with all enhancements included as part of maintenance and upgrades.
**Reputation / proof points**
* ISO 9001:2015 Certified
Additional information
Innovatum's ROBAR system is designed for end-to-end life sciences labeling solutions. They emphasize direct support, with project managers handling customer inquiries and problem resolution, aiming for rapid response times. Their approach ensures that all system enhancements are integrated into the product, simplifying the upgrade process for customers under maintenance. The company offers flexible deployment options, including on-premises, hosted, and SaaS models, all of which are single-tenant to ensure robust security and minimize business interruptions.
Key Highlights
-
Provides the ROBAR Enterprise Label Management System for FDA-regulated industries.
Source
“Innovatum’s ROBAR Enterprise Label Management System for FDA-regulated pharmaceutical, medical device, and biotechnology manufacturers.”
-
Offers direct, tier-one support provided by project managers.
Source
“all support is tier one level provided by project managers who implement the product, and problem resolutions come in minutes instead of days.”
-
ISO 9001:2015 Certified.
Source
“ISO 9001:2015 Certification”
Certifications & Trust Signals
-
ISO 9001:2015 Certified.
Source
“ISO 9001:2015 Certification”
Buyer Snapshot
Best for
- FDA-regulated pharmaceutical, medical device, and biotechnology manufacturers
- Companies seeking enterprise-level labeling and regulatory data management
How engagement typically works
- Direct support from project managers
- All enhancements included with maintenance
Typical deliverables
- ROBAR Enterprise Label Management System
- Regulatory data management (RIMS)
- Label printing integration (PIMS data)
- Submission and approval process management
Good to know
- Best when requiring dedicated, single-tenant hosting for SaaS or hosted solutions.
HQ:
US
Languages:
English
Claim status:
Listed
Services & Capabilities
eIFU & Implant Card Platform
Pricing model:
Custom pricing
Hosting Model:
SaaS
Paper On Request Fulfillment:
Included
Implant Card Support:
Full
Compliance Certifications:
ISO 13485, GDPR, MDR, IVDR
Multilingual Support:
Yes
Qr Or UDI Linking:
Yes
Validation Pack:
Yes
Additional eifu_platform Details
Hosting Details
ROBAR systems are available as on premises, hosted, or SaaS. Hosted and SaaS ROBAR solutions are single-tenant.
Compliance Certifications
ISO 9001:2015 Certified
