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 for FDA-regulated pharmaceutical, medical device, and biotechnology manufacturers. They offer their ROBAR Enterprise Label Management System, available on-premises, hosted, or as SaaS.
**Expertise & scope**
* End-to-end life sciences labeling solutions
* Regulatory data management, including RIMS and PIMS data integration for label printing
* Management of bidirectional regulatory data submissions and approvals using technologies like HL7
* Solutions for hosted or on-premises labeling
* Support for FDA UDI and eIFU requirements
**Reputation / proof points**
* ISO 9001:2015 Certified
* Decades of consistent, extraordinary support, with problem resolutions often in minutes
* Support provided by project managers who implement the product
* Single-tenant hosting and SaaS solutions for enhanced security and minimal business interruptions
Innovatum (eLabeling / eIFU + ePIC) provides enterprise labeling and regulatory data management solutions for FDA-regulated pharmaceutical, medical device, and biotechnology manufacturers. They offer their ROBAR Enterprise Label Management System, available on-premises, hosted, or as SaaS.
**Expertise & scope**
* End-to-end life sciences labeling solutions
* Regulatory data management, including RIMS and PIMS data integration for label printing
* Management of bidirectional regulatory data submissions and approvals using technologies like HL7
* Solutions for hosted or on-premises labeling
* Support for FDA UDI and eIFU requirements
**Reputation / proof points**
* ISO 9001:2015 Certified
* Decades of consistent, extraordinary support, with problem resolutions often in minutes
* Support provided by project managers who implement the product
* Single-tenant hosting and SaaS solutions for enhanced security and minimal business interruptions
Additional information
Innovatum emphasizes a high-touch support model, where phones are answered by people, and all support is tier-one level, provided by project managers. They deliver information on the effective use of their ROBAR system directly to customers under maintenance, avoiding reliance on external support blogs or user groups. Their ROBAR systems can be deployed on-premises, hosted, or as SaaS, with hosted and SaaS options always being single-tenant to ensure robust security and operational continuity. This approach is designed to meet the mission-critical needs of life sciences labeling and data management.
Key Highlights
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Innovatum's ROBAR Enterprise Label Management System is designed for FDA-regulated industries.
Source
“Innovatum’s ROBAR Enterprise Label Management System for FDA-regulated pharmaceutical, medical device, and biotechnology manufacturers.”
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They offer a high level of customer support, with problem resolutions often in minutes.
Source
“problem resolutions come in minutes instead of days.”
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ROBAR systems are available as on-premises, hosted, or SaaS solutions, with hosted and SaaS options being single-tenant.
Source
“ROBAR systems from Innovatum are available as on premises, hosted, or SaaS. Hosted and SaaS ROBAR solutions are always single-tenant.”
Certifications & Trust Signals
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ISO 9001:2015 Certified
Source
“ISO 9001:2015 Certification”
Buyer Snapshot
Best for
- FDA-regulated pharmaceutical, medical device, and biotechnology manufacturers
- Companies seeking end-to-end labeling and regulatory data management
How engagement typically works
- Direct support from project managers
- On-demand information delivery under maintenance
Typical deliverables
- ROBAR Enterprise Label Management System
- Regulatory data management services
- Label printing data integration
- Submission management support
Good to know
- Best when a high level of direct vendor support is prioritized
- Best when single-tenant hosting or on-premises deployment is preferred
Pricing
Model:
Custom pricing
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
Solutions available as on-premises, hosted, or SaaS. Hosted and SaaS ROBAR solutions are single-tenant.
Compliance Certifications
ISO 9001:2015
