Sold by: TytoNyx
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TytoNyx helps medical device teams cut FDA submission assembly from hundreds of hours to under 50 by analyzing evidence gaps and generating structured, submission-ready deliverables.
Overview
Accelerate FDA Submission Readiness for Medical Devices
The Tyto Submission Package from TytoNyx helps medical device manufacturers move from fragmented engineering, cybersecurity, and quality evidence to submission-ready deliverables. 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.
Internal estimates indicate that submission assembly effort can decrease from approximately 300-400 hours to 40-50 hours, depending on documentation readiness and project scope - freeing engineering and quality teams to focus on product development rather than manual document preparation.
About TytoNyx
TytoNyx specializes in AI-driven compliance for medical devices, including FDA and EU MDR requirements, NIST-aligned cybersecurity documentation, regulatory readiness assessments, and technical file assembly. The TytoNyx team brings more than 20 years of medical-device R&D leadership, with experience spanning FDA 510(k) submissions, software lifecycle documentation, risk management, verification and validation, and medical-device cybersecurity. The founder's experience includes leading multiple Class II products through FDA 510(k) clearance at Brain Electrophysiology Laboratory, and DCI international.
The TytoNyx Device Readiness software has completed the AWS Foundational Technical Review and earned the AWS Qualified Software designation.
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 guidance and relevant NIST frameworks, with identified risks, controls, and supporting evidence
- Traceability materials linking requirements, design decisions, risk controls, and verification results to their source records
- eSTAR-ready content organized for the applicable sections of the electronic submission
- Gap reports that identify missing, inconsistent, or unsupported evidence and the actions needed to resolve it
- Review packages that let regulatory and engineering teams inspect source references and approve content before 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 that can set timelines back by weeks or months
- Accelerate submission timelines - Automate the transformation of scattered evidence into structured deliverables, reducing manual preparation burden on engineering and quality teams
- Improve documentation completeness - Systematically assess readiness across engineering, and quality teams
- 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 designed for medical device manufacturers preparing FDA submissions who need to:
- Assemble submission materials more efficiently
- Organize requirements, risk management, testing, and other supporting evidence
- Address cybersecurity documentation requirements when applicable
- Identify gaps and inconsistencies before filing
- Reduce manual effort while improving confidence in submission completeness
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
- Identify documentation gaps before they cause costly FDA delays. TytoNyx analyzes fragmented engineering and quality records to surface missing or inconsistent evidence early in the submission process. By catching gaps before filing, teams reduce the risk of FDA Refuse to Accept decisions that can set timelines back by weeks or months.
- Automatically generate structured, submission-ready deliverables. The platform transforms validated evidence into outputs aligned with FDA expectations, including eSTAR-ready content and cybersecurity documentation mapped to NIST frameworks. This replaces time-intensive manual assembly of regulatory packages and reduces rework caused by formatting errors or incomplete traceability.
- Deploy alongside your existing QMS and 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. The two-stage workflow - evidence analysis followed by deliverable generation - integrates into existing regulatory preparation processes to accelerate time to first usable output.
Details
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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 product per unit, with each unit covering one medical device submission. Two options are available. The first gives you a Device Readiness Assessment, an FDA-readiness report for your device submission. The second adds 510(k) eSTAR preparation to that same readiness report. Both are priced by quantity, so you select the number of units you need. The two options are independent service levels, not tiers you upgrade between. Choose the second option when you want submission preparation included alongside the readiness report.
Top-of-mind questions for buyers
One unit covers one medical device submission. For the first option, you get a readiness report that analyzes your Design History File and flags missing documentation and design-control gaps. For the second option, that same report plus 510(k) eSTAR preparation applies to one submission. You buy a unit per device you plan to submit.
The first option assesses readiness only. It reviews your Design History File and reports gaps and remediation steps. The second option does that assessment and then prepares the 510(k) eSTAR submission. The eSTAR work extracts supporting evidence, maps it to regulatory fields, and drafts missing narratives such as the 510(k) Summary.
Both options are priced by quantity, so you select the number of units you need. Each unit covers one submission. Costs add up per unit; more submissions means more units purchased. The two options are separate service levels, so you choose which applies to each device rather than upgrading between them.
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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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Upon subscribing to this product, you must acknowledge and agree to the terms and conditions outlined in the vendor's End User License Agreement (EULA) .
Content disclaimer
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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.
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.
Pricing Model
TytoNyx uses a per-submission pricing model. The free trial covers one submission, allowing you to evaluate the platform's full workflow. After the free trial ends, additional submissions are available for purchase.
Getting Started
After purchasing through AWS Marketplace, follow these general steps to begin using TytoNyx:
- Activate your subscription through the AWS Marketplace console.
- Complete account setup using the instructions in the AWS Marketplace Subscription Guide (available in Additional Resources).
- Configure your workspace and invite team members as described in the Application User Guide (available in Additional Resources).
- Begin uploading engineering, cybersecurity, and quality evidence for analysis.
- Review the platform's gap analysis results and generate submission-ready deliverables.
The platform uses a two-stage workflow: Evidence Analysis followed by Deliverable Generation. For detailed configuration steps and feature walkthroughs, refer to the guides linked in Additional Resources.
Billing and Refunds
For refund requests or billing inquiries related to your AWS Marketplace subscription, contact TytoNyx support at support@tytonyx.com 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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