Clinical Evaluation of Medical Device Software and Software as a Medical Device

Clinical Evaluation of Medical Device Software and Software as a Medical Device is a training course that explains how to assess and document the clinical safety, performance, and benefit–risk profile of medical device software, including AI and machine learning solutions.

Key Topics

• Clinical evaluation requirements for medical device software
• Clinical safety and performance assessment
• Benefit–risk analysis for software-based medical devices
• AI and machine learning software evaluation
• Clinical data types and evidence generation
• Clinical claims and measurable endpoints
• EU MDR and FDA regulatory differences
• Human factors and clinical risk management
• Literature review and data utilization
• Post-market clinical follow-up considerations
• Regulatory documentation and submission pitfalls
• Lifecycle compliance for medical software

Who should Attend

• Clinical affairs professionals
• Regulatory affairs specialists
• Medical software R&D engineers
• Scientists developing software-based medical devices
• Product and program managers
• Quality assurance professionals