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.
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.
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
Speakers
Zuzanna Kwade,
Agfa HealthcareZuzanna Kwade is Medical Affairs Manager, Agfa Healthcare. Zusanna holds a PhD in Biochemistry and has more than ten years of experience in clinical and medical research. She is the co-author of several white papers on regulatory aspects of clinical research.
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 represents COCIR in the European Union Task Force on clinical evaluation of software.
Who Should Attend
- Clinical and regulatory affairs professionals
- Medical software R&D engineers and scientists
- Product and programme managers
- Quality assurance professionals
