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 offer services specifically designed to facilitate FDA GUDID submissions through a partner workflow, aiming to simplify the process for manufacturers. Their expertise lies in navigating the complexities of regulatory data management and submission requirements.
- **Who they are**
1WorldSync — FDA/GUDID publishing via partner workflow assists companies in managing their regulatory data and submissions, particularly for the FDA's Global Unique Device Identification Database (GUDID).
- **Expertise & scope**
* Facilitates FDA GUDID submissions via a partner workflow.
* Focuses on streamlining the publishing of device identification data.
- **Reputation / proof points**
* Languages: English
- **Who they are**
1WorldSync — FDA/GUDID publishing via partner workflow assists companies in managing their regulatory data and submissions, particularly for the FDA's Global Unique Device Identification Database (GUDID).
- **Expertise & scope**
* Facilitates FDA GUDID submissions via a partner workflow.
* Focuses on streamlining the publishing of device identification data.
- **Reputation / proof points**
* Languages: English
Additional information
For buyers utilizing 1WorldSync — FDA/GUDID publishing via partner workflow, understanding the submission process is key. The service is designed to integrate with existing partner workflows, suggesting a need for clear data mapping and internal process alignment before engagement. Buyers should anticipate a focus on accurate and timely data publication to meet FDA requirements. The primary language of operation and support is English.
Key Highlights
-
Supports FDA/GUDID publishing via a partner workflow.
Source
“FDA/GUDID publishing via partner workflow”
Certifications & Trust Signals
-
Leader in Product Content Orchestration.
Source
“Contact 1WorldSync, the Leader in Product Content Orchestration”
Buyer Snapshot
Best for
- Companies needing to submit UDI data to the FDA GUDID.
- Organizations seeking a streamlined publishing process via a partner workflow.
How engagement typically works
- Partner workflow integration.
- Data submission and management.
Typical deliverables
- Facilitated GUDID submissions.
- Streamlined data publishing.
Good to know
- Best when integrated into existing partner workflows.
- Requires clear data mapping for submission.
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
No
Gdsn Integration
No
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