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AI/ML Test & Validation Services
AI/ML Test & Validation Services
Our AI/ML Test & Validation service delivers a structured, end-to-end approach to secure your AI-powered medical devices and achieve regulatory compliance. We ensure that your models and datasets are validated for performance, fairness, and reliability while meeting FDA, EU MDR, and other global regulatory requirements. This approach builds trust in your AI innovation and reduces risk across the device lifecycle.
AI/ML Test & Validation Services
Our AI/ML Test & Validation Services Process
Creating a documented and compliant test strategy
Activities
- EstablishStandard Operating Procedures (SOPs) for AI algorithm testing.
- Develop comprehensive test plans aligned with FDA’s Good Machine Learning Practice (GMLP) and EU MDR guidelines.
- Review and align with your existing Quality Management Systems (QMS).
Deliverables
- Regulatory-Aligned Test Protocol Document detailing all planned tests.
- Standards Compliance Checklist mapping your test plan to FDA, EU MDR, and AAMI TIR57 requirements.
Activities
- Performance Validation: Measure accuracy, sensitivity, specificity, and generalization across diverse datasets.
- Bias & Fairness Testing: Detect and mitigate demographic bias to ensure equitable model performance.
- Repeatability & Reproducibility Checks: Verify consistency across operators, devices, and labs.
- Cybersecurity Validation: Assess model resilience against adversarial attacks and data manipulation, including cloud-based evaluations, in line with HIPAA and other security policies.
Deliverables
- Performance Validation Report with detailed quantitative results.
- Bias & Fairness Audit Report with actionable recommendations.
- Reproducibility & Integrity Report confirming consistent results.
Activities
- Consolidate all test reports into a cohesive regulatory submission package..
- Develop traceable workflows and a digital audit trail for compliance.
- Draft validation reports suitable for direct inclusion in submissions like FDA 510(k), De Novo, PMA, or EU MDR technical documentation.
Deliverables
- Final Regulatory Submission-Ready Validation Report.
- Complete Digital Audit Trail of all testing and validation activities.
Secure Your Innovation and Achieve Regulatory Compliance
AI and Machine Learning are now integral to medical devices. Our services help you navigate the path to market, ensuring compliance for a New Generation HealthCare
AI-Enabled MedTech Insights for C-Suite Executives 
AI/ML Test & Validation Services - Key Benefits
Building security in from the ground up, not as an afterthought.
Key Benefits
- Ensure your AI/ML models are validated for accuracy, fairness, and robustness, while maintaining a defensible and regulatory-compliant documentation package.
- This strengthens trust with regulators, clinicians, and end users while mitigating clinical and cybersecurity risks.
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
Adopt structured AI/ML testing and validation protocols, implement continuous reproducibility checks, and maintain a clear digital audit trail. Integrate findings into your regulatory submissions and post-market monitoring to ensure long-term compliance and safety.
Looking for Something Else ?
Rigorous testing to ensure the device is ready for regulatory approval and market release.
Contact us today to begin your AI journey with a clear , complaint and actionable plan.
