Post-Market Surveillance and Vigilance of Software as a Medical Device (SaMD) and Medical Device Software (MDSW) Training Course

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.

This course is part of our Vigilance training course collection; for information on the basics of PhV, consider taking a look at our beginner-friendly Pharmacovigilance training course.

Benefits of attending

• Confirm the regulatory requirements for PMS for SaMD & MDSW, and how these are interpreted in ISO 13485, ISO 14971 and various guidance documents. 
• Create a Post-market Surveillance procedure that is both proactive and reactive. 
• Implement cost-effective and targeted PMCF using various techniques. 
• Recognize when a complaint needs to be reported as an adverse event or incident for marked devices.

Who should attend?

This training is suitable for all professionals involved in the post-market surveillance and vigilance of software as a medical device and medical device software, including: 

• Regulatory Professionals
• Quality Managers
• Clinical Affairs Specialists
• Complaint Handling Specialists
• Design and Development Professionals
• EU Authorised Representatives

Enrol/reserve