EU MDR and FDA Clinical Evaluation of Medical Device Software and Software as a Medical Device Training Course (ONLINE EVENT: October 1, 2025) - ResearchAndMarkets.com

DUBLIN--(BUSINESS WIRE)--The "Clinical Evaluation of Medical Device Software and Software as a Medical Device Training Course" training has been added to ResearchAndMarkets.com's offering.

This course will provide a clear understanding of the clinical evaluation requirements and their practical application for software products, including AI/ML-based devices. It will also provide advice on how to determine the type and amount of data needed to sufficiently support the intended medical purpose and (individual) clinical claims, with many practical examples and analysis of differences between the EU MDR and FDA approach.

Whether developing new medical software for more precise diagnosis and targeted treatment or a healthcare app for individuals concerned about their health, manufacturers are tasked to appreciably prove to authorities the safety, quality, and effectiveness of their products.

The evaluation of clinical safety and performance, as well as the overall benefit-risk profile of the product, through a critical assessment of relevant data, is one of the key requirements for the manufacturers of medical device software and a focus area for regulators.

Benefits of attending

• Gain an in-depth understanding of the requirements for clinical evaluation and how to apply them to different types of medical device software, including AI/ML-based devices
• Understand how to establish measurable endpoints for clinical claims
• Find out how to define and generate sufficient clinical and/or performance data to meet the safety and performance requirements of your software device
• Witness the role of human factors and risks
• Learn how to retrieve and use literature data effectively
• Identify residual clinical risks and determine whether post-market clinical follow-up is required
• Provide robust documentation in support of the clinical safety and performance of your device
• Hear about frequent pitfalls of clinical regulatory submissions
• Ensure continuing compliance throughout the software lifecycle

Certifications

• CPD: 6 hours for your records
• Certificate of completion

Who Should Attend:

• Clinical and regulatory affairs professionals
• Medical software R&D engineers and scientists
• Product and programme managers
• Quality assurance professionals

Key Topics Covered:

Introduction to clinical evaluation

• The regulatory framework of gathering clinical evidence for devices and international differences (EU, US and UK.)
• Clinical evaluation during the software lifecycle
• Clinical vs performance evaluation
• Definitions, purpose, deliverables
• Process and key characteristics
• Role of literature and state-of-the-art
• Selecting data sources
• Defining acceptance criteria
• Evaluation of indirect benefits and risks

How to define a scope and a level of clinical evidence for medical device software

• Validation of clinical association, technical performance and clinical performance
• Role of validation and usability
• Considerations for AI/ML - devices

Case studies - clinical evaluation of medical device software

Clinical trials and validation studies

• Selecting appropriate study design and implications
• Development and validation of AI/ML devices (cohort, case-control)
• Clinical performance studies
• Application of standards
• Generating evidence of effectiveness
• Evidence for Health Technology Assessment

Clinical trials and validation studies - continued

• Reporting guidelines and checklists
• Challenges of mHealth trials
• Regulatory and ethical considerations

Clinical evaluation post-market

• Implementing post-market clinical follow-up for medical device software
• Real-world evidence

For more information about this training visit https://www.researchandmarkets.com/r/vz7re4

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