Sold by: TytoNyx
Deployed on AWS
The Tyto Submission Package helps medical device companies accelerate FDA submission readiness by first analyzing fragmented engineering, cybersecurity, and quality evidence, then transforming it into submission-ready deliverables. This helps teams catch documentation gaps earlier, reduce the risk of Refuse to Accept issues, and lower the cost and delay of manual submission preparation.
Overview
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Demo-1.TytonyxEstarAssembly.mp4
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Demo-2.ReviewGeneratedDocuments.mp4
The Tyto Submission Package helps medical device manufacturers accelerate FDA submission readiness by analyzing fragmented engineering, cybersecurity, and quality evidence and transforming it into submission-ready deliverables. Built for software-enabled and cloud-connected medical products, it helps teams surface documentation gaps before submission, improve completeness, and reduce the time, cost, and rework associated with manual regulatory preparation.
The platform works in two stages. In the first stage, Tyto reviews scattered product and quality records across existing workflows to identify missing evidence, inconsistencies, and readiness gaps. In the second stage, it converts the validated evidence into structured outputs that support preparation for FDA submission, including cybersecurity documentation, traceability materials, and eSTAR-ready content. This gives manufacturers a more scalable way to move from development records to submission-ready evidence.
The Tyto Submission Package is built to complement, not replace, the systems teams already use. Working with existing QMS and engineering workflows helps organizations improve regulatory readiness without a major process overhaul. The result is a faster path to submission, lower manual preparation burden, and reduced risk of Refuse to Accept issues and costly review delays.
Highlights
- Accelerate FDA submission readiness by turning fragmented engineering, cybersecurity, and quality records into structured, submission-ready deliverables.
- Reduce medical device compliance delays by surfacing documentation gaps early and helping teams address missing or inconsistent evidence before submission.
- Simplify FDA submission readiness without replacing existing QMS or engineering workflows, lowering manual preparation effort and reducing rework.
Details
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Delivery method
Deployed on AWS
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Pricing
Pricing is based on the duration and terms of your contract with the vendor. This entitles you to a specified quantity of use for the contract duration. If you choose not to renew or replace your contract before it ends, access to these entitlements will expire.
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Dimension | Description | Cost/36 months |
|---|---|---|
Device Readiness Assessment | FDA-readiness report for a medical device submission | $12,000.00 |
Device Readiness Assessment and eSTAR preparation | FDA-readiness report and 510(k) eSTAR preparation | $18,000.00 |
Dimensions summary
You buy this platform through a contract, priced per unit. Each unit covers one medical device submission. Two options are available. The Device Readiness Assessment unit gives you an FDA-readiness report that reviews your device documentation. The Device Readiness Assessment and eSTAR preparation unit adds 510(k) eSTAR submission preparation to that report. The two options are independent choices, not tiers. Pick the assessment-only unit if you need a readiness review. Pick the combined unit if you also need help preparing the 510(k) eSTAR submission. Cost scales with the number of device submissions you purchase.
Top-of-mind questions for buyers
One unit covers a single medical device submission. You buy one unit per device you want assessed. The unit produces one FDA-readiness report for that device. If you have several devices moving toward submission, you purchase a matching number of units.
The Device Readiness Assessment unit reviews your Design History File and reports missing documentation, design-control gaps, and remediation steps. The Device Readiness Assessment and eSTAR preparation unit adds 510(k) eSTAR preparation, converting your file into a populated FDA eSTAR submission. Choose based on whether you need submission assembly.
The two options are independent units, not stacked tiers. You can purchase the assessment-only unit now for a readiness review. If you later need submission assembly, you would buy the combined unit. Purchasing the combined unit gives you both the readiness report and 510(k) eSTAR preparation together.
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Vendor refund policy
Refund requests must be submitted in writing to support@tytonyx.com . TytoNyx will review refund requests for initial purchases made in error, duplicate charges, or material failure of the service to perform as described. Refund requests must be made within 14 days of first usage.
Refunds are not available for partial use, change of mind, failure to use the service, or after substantial use of the product, including completion of analysis or generation of deliverables.
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Delivery details
Software as a Service (SaaS)
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Resources
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Support
Vendor support
TytoNyx provides product support for onboarding, setup, configuration, and ongoing use of submission-readiness workflows. Buyers receive email-based support with initial response within 1 business day for standard requests and expedited triage for critical issues affecting core platform functionality. Support covers user access, evidence processing workflows, troubleshooting, and general product guidance.
Support email: support@tytonyx.com
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