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Regulators Now Treat AI as High-risk Technology In Healthcare
AI/ML Regulatory Readiness Assessments
Regulatory readiness for AI/ML medical devices is more than a checklist - it's a strategic process. Our service provides a clear, phased roadmap to navigate complex governance, validation, and documentation requirements, ensuring your AI-enabled device is fully prepared for a seamless regulatory submission while maintaining safety, transparency, and compliance with global standards.
Our AI/ML Regulatory Readiness Assessments Process
Regulatory readiness for AI/ML medical devices is more than a checklist - it's a strategic process.
Activities
- Review and define AI/ML governance framework
- Assess current risk management documentation (ISO 14971, NIST Cybersecurity Framework)
- Identify gaps in cybersecurity and regulatory compliance
Deliverables
- Initial Readiness & Gap Analysis Report, Actionable Recommendations
Activities
- Validate dataset integrity and perform bias assessment
- Verify model performance metrics and robustness against cyber-attacks
- Conduct red-team penetration testing and assess explainability
Deliverables
- Technical Validation & Testing Report, Adversarial Threat Modeling Documentation
Activities
- Finalize Technical File / Design Dossier and regulatory documentation
- Develop post-market surveillance plan and independent audit trail
- Ensure all SOPs are documented and aligned
Deliverables
- Complete Regulatory-Ready Submission Package, Strategic Post-Market Surveillance Roadmap
Ready to Secure Your Device and Go to Market Faster?
Regulators now treat AI as high-risk technology in healthcare. Without validation, explainability, and compliance evidence, AI-powered devices cannot get approved or trusted.
AI/ML Regulatory Readiness Assessments - Key Benefits
Building security in from the ground up, not as an afterthought.
Key Benefits
- Ensures your AI/ML medical device meets global regulatory standards while validating model integrity, robustness, and data governance.
- Accelerates approval timelines and builds stakeholder trust by mitigating compliance and cybersecurity risks.
- Provides end-to-end regulatory readiness, validating AI/ML model integrity, bias mitigation, and cybersecurity compliance, enabling faster approval and trusted market adoption.
Why Our Structured Approach Matters
This tailored approach directly supports our core differentiator—the integrated, end-to-end solution by focusing on All-in-One AI/ML and Cybersecurity Solution, from Report to Roadmap and continuous partnership Premarket to Post-Market.
Key Recommendation for
Manufacturers
Integrate regulatory readiness and cybersecurity early in the AI/ML development lifecycle, maintain comprehensive documentation and audit trails, and implement continuous post-market surveillance to ensure ongoing compliance and patient safety. Integrate regulatory checks early, maintain comprehensive documentation and audit trails, and implement continuous post-market surveillance for AI/ML devices to ensure ongoing compliance and safety.
Looking for Something Else ?
Rigorous testing to ensure the device is ready for regulatory approval and market release.
Contact us to schedule a consultation and take the first step toward a secure and compliant product.
