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
1WorldSync — FDA/GUDID publishing via partner workflow is a provider focused on streamlining regulatory submissions for medical devices. They specialize in FDA GUDID submissions through a partner workflow, aiming to simplify compliance processes for manufacturers. Their services are designed to assist companies in navigating the complexities of regulatory data management and submission requirements.
Additional information
For companies utilizing the 1WorldSync — FDA/GUDID publishing via partner workflow, understanding the submission process is key. This service is designed to integrate with existing partner workflows, suggesting a need for clear data mapping and communication protocols between the manufacturer and 1WorldSync. Buyers should consider how their current data management systems align with the requirements for GUDID submissions to ensure a smooth integration and efficient processing of their regulatory data.
Key Highlights
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Offers world-class image capture assets that users own for life.
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“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.
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“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.
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“Aggregate, validate & communicate product content & integrate with your ERP”
Certifications & Trust Signals
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Leader in Product Content Orchestration.
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“Contact 1WorldSync, the Leader in Product Content Orchestration”
Buyer Snapshot
Best for
- Medical device manufacturers needing FDA GUDID submission support.
- Companies seeking to streamline their regulatory publishing processes.
How engagement typically works
- Partner workflow integration.
- Specialized submission support.
Typical deliverables
- Assistance with FDA GUDID data publishing.
- Streamlined submission process management.
Good to know
- Best when integrated with existing partner workflows.
- Requires clear data mapping for GUDID requirements.
HQ:
US
Languages:
English
Claim status:
Listed
Services & Capabilities
FDA GUDID Submission Tools
Pricing model:
Custom pricing
Submission Route:
managed_service
Generates Spl:
Yes
Handles Esgsubmission:
Yes
Validation Tools:
Yes
Gdsn Integration:
Yes
Additional gudid_submission_tools Details
Submission Route
direct_spl
Generates Spl
Yes
Handles Esgsubmission
Yes
Validation Tools
Yes
Gdsn Integration
Yes
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