TytoNyx Inc

TytoNyx helps medical-device and digital-health companies reach FDA submission, pass quality and hospital security reviews, and launch securely on AWS. We combine QA/RA, SaMD engineering, cybersecurity, HIPAA, and cloud implementation under one accountable team.

We combine regulatory strategy, quality systems, software lifecycle compliance, cybersecurity and cloud implementation—so clients do not have to coordinate separate regulatory, security and engineering consultants.

OUR CORE SERVICES

FDA and U.S. market access
• 510(k), eSTAR and De Novo readiness
• Regulatory strategy and submission-gap assessments
• Intended use, classification and predicate analysis
• Submission documentation review and assembly

Medical-device quality systems
• ISO 13485 and FDA QMS implementation
• Design controls, risk management and traceability
• CAPA, change control, supplier controls and audit readiness
• Practical QMS programs built for startups and scaling companies

SaMD and AI/ML compliance
• IEC 62304 software lifecycle documentation
• Software requirements, architecture, SOUP and traceability
• Verification and validation strategy
• AI/ML dataset governance, performance validation and PCCP support

Medical-device cybersecurity
• FDA cybersecurity readiness
• Threat modeling and security risk management
• SBOM and vulnerability-management workflows
• Security architecture, testing strategy and penetration-test readiness

HIPAA and AWS
• HIPAA security-risk assessments
• AWS architecture and technical safeguards
• Access control, audit logging, incident response and vendor readiness
• Policies, evidence and customer-security-questionnaire preparation

WHY TYTONYX

Our leadership brings:

• Our principals led the technical, quality, and regulatory execution of two FDA-cleared Class II SaMD products.
• Class I and II market-access experience across 20+ countries
• Hands-on FDA, EU MDR, ISO 13485, IEC 62304 and MDSAP experience
• Deep experience connecting product engineering with regulatory documentation
• TytoNyx is an AWS Partner, and our Device Readiness software successfully completed the AWS Foundational Technical Review.