Presented by
Management Forum
Clinical Evaluation of Medical Device Software In-house Training
This one-day course will provide a clear understanding of the clinical evaluation requirements and their practical application for software products, including AI/ML-based devices.
- Format: Live online
- CPD: 6 hours for your records
- Certificate of completion
Course overview
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 a medical device software and a focus area for regulators.
This course will provide a clear understanding of the 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 EU MDR and FDA approach.
This course is of our range of Medical Devices training courses - now also including Medical Devices Cyber Security training to help improve your data security.
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 software lifecycle
Who should attend
- Clinical and regulatory affairs professionals
- Medical software R&D engineers and scientists
- Product and programme managers
- Quality assurance professionals
This course will cover:
Introduction to clinical evaluation
- The regulatory framework of gathering clinical evidence for devices and international differences (EU, US and UK…)
- Clinical evaluation during 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 implictions
- Development and validation of AI/ML-devices (cohort, case-control)
- Clinical performance studies
- Application of standards
- Generating evidence of effectiveness
- Evidence for Heath 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
Zuzanna Kwade
Dedalus Healthcare
Zuzanna Kwade is Software Clinical Evaluation Lead at Dedalus Healthcare. Zuzanna holds a PhD in Biochemistry and has 15 years of experience in clinical and medical research. She is the co-author of several white papers on regulatory aspects of clinical research and clinical evaluation.
Since 2016, she has been actively involved in Clinical Evaluations according to MEDDEV 2.7.1 (Rev.4) for multiple devices, including high risk hardware devices and medical software. She also represented COCIR in the European Union Task Force on clinical evaluation of software and co-authored MDCG2020-1 guidance on clinical evaluation of MDSW.
