1WorldSync — FDA/GUDID publishing via partner workflow
Cruxi Inc.
Cruxi offers AI-powered regulatory submission services for medical devices, streamlining processes like FDA 510(k), De Novo, and PMA. They provide expert guidance and automated compliance checks.
Cruxi provides a comprehensive, AI-powered platform designed to simplify medical device regulatory submissions. Their services cover a wide range of FDA and global market needs, including FDA 510(k), De Novo Classification Requests (eSTAR), Q-Submissions, and PMA Supplements. Leveraging intelligent automation and expert guidance, Cruxi aims to streamline the entire submission workflow, from device classification to the final package, ensuring automated compliance checks at every step. They offer specialized solutions for traditional 510(k) submissions, which typically have a 90-day FDA review period. For novel, low to moderate-risk devices, Cruxi supports the mandatory eSTAR use starting October 1, 2025. Additionally, their platform facilitates formal device classification determinations and supports 180-day, Real-Time supplements with repeatable templates and checklists, making regulatory processes more efficient and manageable for manufacturers.
About
**Who they are**
1WorldSync — FDA/GUDID publishing via partner workflow is a leader in product content orchestration, offering solutions for managing and communicating product information. They focus on streamlining processes related to product data for various industries.
**Expertise & scope**
* Expert managed services and technology for sourcing, creating, and validating product content.
* Aggregation, validation, and communication of product content, with integration capabilities for ERP systems.
* Solutions for product information management (PIM) software.
* Support for content creation, including product photography and GS1 product images.
* Item setup automation services.
* Sales automation platform for VARs and MSPs.
* Program development for maximizing conversions through ratings and reviews.
**Reputation / proof points**
* Offers world-class image capture assets that users own for life.
1WorldSync — FDA/GUDID publishing via partner workflow is a leader in product content orchestration, offering solutions for managing and communicating product information. They focus on streamlining processes related to product data for various industries.
**Expertise & scope**
* Expert managed services and technology for sourcing, creating, and validating product content.
* Aggregation, validation, and communication of product content, with integration capabilities for ERP systems.
* Solutions for product information management (PIM) software.
* Support for content creation, including product photography and GS1 product images.
* Item setup automation services.
* Sales automation platform for VARs and MSPs.
* Program development for maximizing conversions through ratings and reviews.
**Reputation / proof points**
* Offers world-class image capture assets that users own for life.
Additional information
1WorldSync provides comprehensive product content orchestration, enabling businesses to manage and distribute product information effectively. Their services cover the entire lifecycle of product content, from creation and validation to aggregation and integration with enterprise resource planning (ERP) systems. They also offer specialized solutions for product photography and item setup automation. For technical support and resources, or to explore plans and pricing, users can access dedicated sections on their platform. Engagement with 1WorldSync can be initiated through their contact us pages, which direct inquiries to specific departments like Technical Support, Billing, General Inquiries, and Sales.
Key Highlights
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Offers world-class image capture assets that users own for life.
Source
“World-class image capture assets you own for life”
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Provides expert managed services and technology for sourcing, creating, and validating product content.
Source
“Expert managed services & tech for sourcing, creating & validating product content”
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Enables aggregation, validation, and communication of product content with ERP integration.
Source
“Aggregate, validate & communicate product content & integrate with your ERP”
Certifications & Trust Signals
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Leader in Product Content Orchestration.
Source
“Contact 1WorldSync, the Leader in Product Content Orchestration”
Buyer Snapshot
Best for
- Companies seeking to centralize and manage product content.
- Businesses needing to integrate product data with ERP systems.
- Organizations requiring expert services for product content creation and validation.
How engagement typically works
- Managed services for product content.
- Technology solutions for product information management.
- Direct sales and business development engagement.
Typical deliverables
- Validated product content.
- Product photography assets.
- Integrated product information management systems.
- Automated item setup.
Good to know
- Best when requiring structured product data management and distribution.
HQ:
US
Languages:
English
Status:
listed
Services & Capabilities
FDA GUDID Submission Tools
Pricing model:
Custom pricing
Submission Route:
direct_spl
Generates Spl:
Yes
Handles Esgsubmission:
Yes
Validation Tools:
Yes
Gdsn Integration:
No
Additional gudid_submission_tools Details
Submission Route
direct_spl
Generates Spl
Yes
Handles Esgsubmission
Yes
Validation Tools
Yes
Gdsn Integration
Yes
