Clinical Trials for Software as a Medical Device (SaMD)
Navigate Clinical and Regulatory Complexities of SaMD with Confidence
What is SaMD?
Software as a Medical Device (SaMD) refers to software intended for medical use without being part of a physical hardware medical device. Examples include:
AI algorithms that assist in diagnosis or detection (e.g., radiology, dermatology, oncology)
Digital therapeutics for mental health or chronic conditions
Predictive analytics tools for hospital readmission or treatment response
Mobile health (mHealth) apps with regulated functionality
To meet global regulatory requirements, SaMD must demonstrate clinical safety, effectiveness, and performance in real-world use.
Our SaMD Clinical Trial Services
Regulatory Classification & Strategy
Determine SaMD regulatory classification and submission pathway (e.g., 510(k), De Novo, PMA)
Identify needs for Pre-Cert, Q-Sub, or Breakthrough Device Designation
Develop multijurisdictional regulatory roadmap
Clinical Protocol Design
Tailor clinical investigation plans to software endpoints
Define accuracy, sensitivity, specificity, and usability outcomes
Address real-world data (RWD) and real-world evidence (RWE) strategy
Technical & Algorithm Support
Validate AI/ML model performance and bias mitigation
Define algorithm change management strategy
Address cybersecurity, interoperability, and data integrity
Study Operations & Execution
Conduct feasibility, site selection, and onboarding
Manage data flow, monitoring, and adherence in software trials
Capture usability feedback from patients and providers
Data Analysis & Regulatory Reporting
Perform statistical analysis of software performance
Prepare CSRs, validation reports, and labeling evidence
Integrate data into regulatory submissions
Why Choose dicentra?
Deep experience with AI, digital health, and software-based diagnostics
Regulatory and clinical teams under one roof
Proven success with SaMD and digital health submissions
Global execution and multi-region regulatory expertise
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