Course overview
This intensive course provides a comprehensive overview of regulatory obligations, risk management, incident reporting, and corrective actions, together with practical tips to ensure that such products remain compliant and safe throughout their lifecycle.
Post-market surveillance (PMS), post-market clinical follow-up (PMCF), complaints, and vigilance handling are vital to ensure compliance of digital health technologies with or without the use of artificial intelligence. In this practical one-day course, you will learn the regulatory requirements needed for successful PMS, PMCF and vigilance of digital health technologies (DHTs). The intensive course will exemplify how proactive and reactive sources of information are essential in PMS procedures of such devices. Also, the course will highlight why developing a PMS plan and PMCF early in software development, will ensure that different sources of information can be targeted to enable a cost-effective product launch. Identifying the right post-market information will assure continued compliance and will trigger consumer shifting needs, enabling a total product life cycle development, and continous value creation in the post-market chain.
The program will be highly interactive, using real-life examples and state-of-the-art practices across different global jurisdictions. Practical insights will be provide, hands-on exercises, and case studies to guide you through the intricate decisions needed that affect your market access processes.
The course will cover:
- Overview of PMS requirements for SaMD and MDSW in different global regulatory frameworks (e.g., EU MDR, USA FDA).
- Understand Risk Management and PMS Planning: a PMS plan tailored for software products.
- Monitoring and Data Collection: insights on the use of real-world data and user feedback to improve product safety and performance.
- Incidence reporting and vigilance:
- Identifying reportable events, incidents, and serious adverse events.
- Regulatory requirements for vigilance reporting and timelines.
- Corrective and Preventive Actions (CAPA)
- Ensuring continuous product improvement through PMCF: changes to the benefit-risk profile and intended-use.
CPD Hours: 6
Course Content
- Day 1
- Overview of requirements
- Understand risk management and PMS planning
- Monitoring and data collection
- Day 2
- Incidence reporting and vigilance
- Corrective and Preventive Actions (CAPA)
- Ensuring continuous product improvement through PMCF
Speakers
Catarina Carrao
Catarina Carrão is the founder of BioSciPons, a life sciences research organisation specialising in health technologies clinical development, evaluation and assessment, with expertise in AI/ML-enabled technologies. She co-ordinates expert teams to bridge the gap between innovation and regulatory compliance, helping developers navigate complex requirements while meeting the expectations of Notified Bodies and the FDA.
Catarina's academic background includes a Marie-Curie Fellowship at Charité Berlin, and Postdoctoral Fellowship at Yale's University Cardiovascular Research Center. She is a Fellow of the American Heart Association (FAHA) since 2013, Delegate of the European Society of Cardiology (ESC), and Professional member of the Health Technology Assessment International (HTAi) organization. She is an expert for the European Commission HaDEA on clinical investigations and Digital Health Technologies, and for the European Innovation and Technology (EIT) Council Health Cluster.
She has presented at RAPS Euroconvergence, the ESC Digital & AI Summit, and DIA Europe on AI/ML medical device regulation, post-market monitoring, and reimbursement pathways. Her recent publications include book chapters and articles on machine learning best practices, AI trustworthiness, and EU MDR/IVDR clinical evaluation.
