SaMD (Software as a Medical Device) CRO In India
- Performance evaluation
- Scientific validity
- Analytical and clinical performance
- Market data analysis
Medical Device Clinical Trials
SaMD Clinical Validation Excellence:
BioAgile Therapeutics delivers comprehensive clinical validation expertise for Software as a Medical Device (SaMD), supporting innovators across every stage of the device lifecycle. From regulatory-focused study design and human clinical trials to post-market surveillance and real-world evidence generation, our team ensures decisive validation of safety, performance, and reliability. By blending robust clinical research methods with advanced algorithm assessment and ongoing risk management, BioAgile advances SaMD products that are safe, effective, and compliant with the latest FDA regulations.
FDA Regulatory Pathway Mastery
FDA Regulatory Pathway Mastery- FDA 510(k) SaMD pathway timelines
- Pre-submission program guidance
- FDA AI/ML guidance compliance (2021 Action Plan)
- Predicate device strategy
Clinical Evidence Generation
BioAgile delivers clinical evidence excellence by building programs around the core pillars mandated by FDA and IMDRF: valid clinical association, analytical validation, and clinical validation. We design and execute rigorous bench and usability tests to ensure SaMD accuracy, sensitivity, and reliability. Our clinical validation protocols centre on real-world scenarios—proving device impact and safety in the intended patient population.
Our team excels at integrating real-world evidence, harnessing EHRs, patient registries, and surveillance data to support primary submissions and ongoing FDA clearance for innovative SaMD products.
AI/ML Algorithm Validation
We conduct deep algorithm benchmarking against established predicate devices—delivering the performance transparency regulators demand. Our framework covers both verification (bench tests for correct builds) and validation (clinical/user studies that confirm intended use), ensuring our clients’ SaMD solutions are robust, reproducible, and regulatory-ready.
Cybersecurity & Data Protection
BioAgile implements advanced cybersecurity and data protection across every SaMD project. Our security architecture aligns with FDA’s latest guidance on medical device security—prioritizing secure design, lifecycle risk management, and ongoing vulnerability monitoring. We enable complete compliance with HIPAA and GDPR, safeguarding sensitive health data in storage, handling, and transmission.
Our post-market protocols include rapid surveillance and incident response for connected or cloud-based SaMD, keeping patient information and device functionality protected at all times.
Post-Market Performance Monitoring
BioAgile proactively conducts structured post-market clinical studies and integrates real-world monitoring to ensure ongoing device safety and effectiveness. We leverage the power of real-world evidence to drive regulatory compliance and continuous product improvement—helping our clients sustain market leadership and deliver trusted healthcare outcomes.
Case Snapshots
Case 1 – Digital Cough Sound Collection (India)
A US-based pilot study collected digital cough recordings from patients suspected of COVID-19 to support AI diagnostic tools. BioAgile managed the study, producing a high-quality dataset that enabled AI training for respiratory disease detection.
Case 2 – Algorithm Development for Metabolic Health
This study developed a predictive algorithm for metabolic health in non-diabetic and at-risk South Asian individuals using continuous glucose monitoring (CGM) devices. BioAgile managed study design, data integration, quality control, and risk assessment, delivering a validated AI-driven tool for personalized metabolic interventions.
International Market Access Support – Regulations Guidance
Trusted By
