Sold by: TytoNyx
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Tytonyx helps medical device teams accelerate FDA submission readiness by analyzing fragmented evidence and transforming it into structured, submission-ready deliverables.
Overview
Accelerate FDA Submission Readiness for Software-Enabled Medical Devices
The Tyto Submission Package from TytoNyx helps medical device manufacturers move from fragmented engineering, cybersecurity, and quality evidence to submission-ready deliverables. Built for software-enabled and cloud-connected medical products, the platform leverages AI-driven compliance capabilities to help teams surface documentation gaps before submission, improve completeness, and reduce the time, cost, and rework associated with manual regulatory preparation.
TytoNyx specializes in AI-driven compliance for medical devices, with capabilities spanning FDA and NIST cybersecurity documentation, regulatory readiness assessment, technical file assembly, and HIPAA support.
How It Works
The platform operates in two stages to transform scattered records into structured, submission-ready evidence:
Stage 1 - Evidence Analysis and Gap Identification Tyto reviews product and quality records across your existing workflows to identify missing evidence, inconsistencies, and readiness gaps. Rather than requiring teams to manually audit documentation, the platform systematically surfaces what is incomplete or misaligned before you reach the submission stage.
Stage 2 - Structured Deliverable Generation Once evidence is validated, Tyto converts it into structured outputs that support FDA submission preparation, including:
- Cybersecurity documentation aligned with FDA and NIST frameworks
- Traceability materials linking requirements to verification evidence
- eSTAR-ready content formatted for electronic submission
This two-stage approach gives manufacturers a scalable path from development records to submission-ready evidence packages.
Key Outcomes for Medical Device Teams
- Reduce Refuse to Accept risk - Identify documentation gaps and inconsistencies before submission, lowering the chance of costly FDA review delays
- Accelerate submission timelines - Automate the transformation of scattered evidence into structured deliverables, reducing manual preparation burden
- Improve documentation completeness - Systematically assess readiness across engineering, cybersecurity, and quality records
- Strengthen cybersecurity compliance - Generate cybersecurity documentation that addresses FDA and NIST requirements for connected medical devices
- Minimize process disruption - Work alongside your existing QMS and engineering workflows without requiring a major process overhaul
Built to Complement Your Existing Workflows
The Tyto Submission Package is designed to integrate with the systems your team already uses. Rather than replacing your QMS or engineering tools, the platform works alongside existing workflows to improve regulatory readiness. This means teams can adopt the platform without overhauling established processes, reducing implementation friction and accelerating time to value.
Who This Is For
The Tyto Submission Package is purpose-built for medical device manufacturers developing software-enabled or cloud-connected products who need to:
- Prepare FDA submission packages more efficiently
- Address cybersecurity documentation requirements for connected devices
- Reduce manual effort in assembling and validating regulatory evidence
- Improve confidence in submission completeness before filing
Get Started
To learn more about how the Tyto Submission Package can support your regulatory readiness goals, contact the TytoNyx team to schedule a consultation or request a guided walkthrough of the platform.
Highlights
- Catch documentation gaps before they become costly delays. TytoNyx analyzes fragmented engineering, cybersecurity, and quality records to surface missing or inconsistent evidence early in the submission process. By identifying gaps before filing, teams reduce the risk of FDA Refuse to Accept decisions that can set timelines back by weeks or months.
- Generate structured, submission-ready deliverables automatically. The platform transforms validated evidence into outputs aligned with FDA expectations, including eSTAR-ready content and cybersecurity documentation mapped to frameworks like NIST. This replaces time-intensive manual assembly and reduces rework caused by formatting errors or incomplete traceability.
- Deploy without disrupting your existing QMS or engineering workflows. TytoNyx complements the tools and processes your team already uses rather than requiring migration to a new system. Teams can adopt the platform alongside current quality management and engineering environments, lowering adoption risk and accelerating time to first usable output.
Details
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Deployed on AWS
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AWS Marketplace now accepts line of credit payments through the PNC Vendor Finance program. This program is available to select AWS customers in the US, excluding NV, NC, ND, TN, & VT.
Pricing
Free trial
Try this product free according to the free trial terms set by the vendor.
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.
Additional AWS infrastructure costs may apply. Use the AWS Pricing Calculator to estimate your infrastructure costs.
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 by the unit, where each unit covers one medical device submission. Two options are available. The Device Readiness Assessment unit delivers an FDA-readiness report that reviews your device documentation and flags gaps. The Device Readiness Assessment and eSTAR preparation unit adds 510(k) eSTAR submission preparation to that same readiness report. The two options are independent, not tiers. You pick based on whether you need the readiness report alone or also want the eSTAR preparation step. Pricing scales with the number of device submissions you process.
Top-of-mind questions for buyers
One unit covers a single medical device submission. For the Device Readiness Assessment unit, you get one FDA-readiness report per device. The assessment reviews your Design History File, flags missing documentation, and identifies design-control gaps. If you process several device submissions, you buy one unit for each device.
The Device Readiness Assessment and eSTAR preparation unit includes the same readiness report, then converts your Design History File into a populated 510(k) eSTAR submission. It extracts supporting evidence, maps it to structured regulatory fields, and drafts missing narratives such as the 510(k) Summary.
The two units are independent, not tiers. Pick the Device Readiness Assessment unit if you need only the readiness report. Pick the Device Readiness Assessment and eSTAR preparation unit if you also need the submission assembled. Each covers one device submission, so cost scales with the number of devices you process.
tytonyx.com
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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.
Legal
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Delivery details
Software as a Service (SaaS)
SaaS delivers cloud-based software applications directly to customers over the internet. You can access these applications through a subscription model. You will pay recurring monthly usage fees through your AWS bill, while AWS handles deployment and infrastructure management, ensuring scalability, reliability, and seamless integration with other AWS services.
Resources
Vendor resources
Support
Vendor support
TytoNyx provides product support for onboarding, setup, configuration, and ongoing use of submission-readiness workflows.
Support Channels
- Email: support@tytonyx.com
Response Times
- Standard requests: Initial response within 1 business day
- Critical issues affecting core platform functionality: Expedited triage
Coverage
Support covers user access and provisioning, evidence processing workflows, troubleshooting platform errors, and general product guidance. If you experience issues using the service or need assistance with your subscription, contact the support team at the email address above.
Getting Started
After purchasing through AWS Marketplace, refer to the AWS Marketplace Subscription Guide and Application User Guide available in the Additional Resources section for step-by-step instructions on account activation and initial configuration.
For refund requests or billing inquiries related to your AWS Marketplace subscription, contact TytoNyx support or manage your subscription directly through the AWS Marketplace console.
AWS infrastructure support
AWS Support is a one-on-one, fast-response support channel that is staffed 24x7x365 with experienced and technical support engineers. The service helps customers of all sizes and technical abilities to successfully utilize the products and features provided by Amazon Web Services.
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