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+1 4087346337 Powering safe, compliant AI under global medical regulations
FDA & EU MDR AI Compliance Support
FDA & EU MDR AI Compliance Support
Navigating regulatory approval for AI-enabled medical devices in the U.S. and Europe is complex. Our unified service ensures compliance with both FDA and EU MDR/AI Act requirements, covering governance, validation, technical documentation, and submission readiness. This structured approach accelerates market access while maintaining safety, cybersecurity, and regulatory transparency.
Our FDA & EU MDR AI Compliance Support Process
Navigating regulatory approval for AI-enabled medical devices in the U.S. and Europe is complex.
Activities
- Determine regulatory pathways: 510(k), De Novo, PMA (FDA) and AI Classification (EU)
- Conduct cybersecurity threat modeling and vulnerability assessments
- Review governance and risk management policies (ISO 14971)
Deliverables
- Joint Regulatory Strategy & Compliance Plan, Threat Model & Initial Risk Assessment
Activities
- Prepare Technical Files, 510(k) documentation, and GSPR compliance statements
- Conduct cybersecurity, data integrity, and bias/fairness testing
- Develop GMLP, AI change control (PCCP), and Total Product Lifecycle (TPLC) plans
- Compile clinical evidence and performance evaluations
Deliverables
- Complete Regulatory-Ready Technical File & Submission Package, Detailed Validation & Testing Reports
Activities
- Finalize submission dossiers for FDA and Notified Bodies
- Manage communications and provide audit readiness support
- Develop post-market surveillance plans and continuous improvement roadmaps
Deliverables
- Completed Submission & Audit-Ready Dossier, Post-Market Surveillance and Adaptive Model Support 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.
FDA & EU MDR AI Compliance Support - Key Benefits
Building security in from the ground up, not as an afterthought.
Key Benefits
- Ensures AI-enabled medical devices comply with both FDA and EU MDR/AI Act standards, enhancing regulatory readiness, cybersecurity, and model transparency while accelerating time to market.
- Streamlines dual-market regulatory approval, ensuring AI/ML devices meet FDA and EU MDR/AI Act standards.
- Enhances cybersecurity, data integrity, and model transparency while accelerating time to market.
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
Start dual-path regulatory planning early, maintain thorough validation and documentation, and implement continuous post-market surveillance to sustain compliance and safeguard patient safety. Implement dual-path regulatory planning early, maintain comprehensive validation and documentation, and establish continuous post-market monitoring to ensure long-term compliance and patient 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.
