Accelerating safe, compliant, and successful AI innovation in healthcare
AI Medical Device Clinical Trials
At Bioexcel, we specialise in designing and conducting AI medical device clinical trials that meet global regulatory standards while addressing the unique challenges of artificial intelligence in healthcare. From protocol design to post-market clinical follow-up, we provide end-to-end CRO services for manufacturers of AI/ML-based software (SaMD) and medical devices.
Our Services for AI Clinical Trials
Clinical Investigation Design & Strategy
Tailored protocol development for AI/ML devices (ISO 14155:2020, EU MDR Annex XV). Study designs for diagnostic accuracy, usability, and performance endpoints (sensitivity, specificity, and ROC curves). Sample size calculation and justification for AI algorithm validation.
Data Management & Algorithm Validation
Real-world dataset curation (retrospective + prospective). Secure data annotation, labeling, and de-identification (GDPR/HIPAA compliant). Algorithm validation & bias testing (cross-validation, drift analysis). Usability & human factors studies for AI-enabled devices.
Regulatory Submissions & Approvals
Preparation of CIP, IB, and Ethics Committee submissions. Clinical Evaluation Report (CER), Clinical Evaluation Plan (CEP), and PMCF plans for AI devices. Expertise with EU MDR/IVDR, FDA SaMD, CDSCO India, IMDRF AI guidance.
Site & Patient Management
Site selection with AI/ML infrastructure and imaging capabilities. Patient recruitment strategies ensuring diverse, representative datasets. Digital solutions: eConsent, eCRF, remote monitoring.
Risk & Compliance Oversight
AI-specific risk management (bias, cybersecurity, algorithm drift). Integration with materiovigilance and complaint handling systems. Ongoing PMS/PMCF studies for adaptive AI systems.
Post-Market Evidence Generation
Hybrid retrospective + prospective studies for real-world performance. Registry creation and management for continuous AI learning. Post-Market Clinical Follow-up (PMCF) execution.
Technology & Innovation Support
Integration of AI data pipelines into trial workflows. Cloud-based platforms for secure, scalable trial data management. Support in preparing AI explainability and transparency documentation for regulators.
Why Choose Bioexcel for AI Medical Device Trials?
AI Clinical Validation Expertise
Expert in planning and executing clinical trials for AI/ML-based medical devices (SaMD) to ensure accuracy, safety, and performance.
Global Regulatory Mastery
Proven knowledge of EU MDR, US FDA, CDSCO, and IMDRF frameworks to accelerate regulatory approvals worldwide
Proven Post-Market Vigilance
Strong track record in materiovigilance and PMS, ensuring ongoing safety and compliance after market launch.
End-to-End CRO Support
Providing complete support from feasibility to approval, including design, site management, data analysis, and submissions.
Ready to Accelerate Your AI Medical Device to Market?
Partner with Bioexcel to design, validate, and gain regulatory approval for your AI/ML-powered medical device
