Artificial intelligence (AI) and machine learning are rapidly being adopted across life sciences—from software-enabled medical devices and diagnostics to manufacturing, quality systems, and regulatory operations. As adoption accelerates, regulatory professionals face an important new challenge: how to govern AI systems in a manner that is controlled, transparent, risk-based, and aligned with existing compliance expectations. While traditional frameworks such as IEC 62304, ISO 13485, and ISO 14971 provide strong foundations for software quality and risk management, AI introduces additional considerations such as model drift, data dependency, explainability, human oversight, accountability, and ongoing performance monitoring.
ISO/IEC 42001 is the first international management system standard designed specifically for AI governance. It provides a practical framework for establishing policies, roles, controls, risk management processes, and continual improvement mechanisms for AI systems across their lifecycle. This session will explain what ISO 42001 means for life sciences organizations, how it complements existing regulatory and quality frameworks, and how companies can begin implementing practical AI governance without overhauling their current quality management system (QMS). Attendees will leave with actionable insights to assess readiness, close governance gaps, and prepare for evolving regulatory expectations surrounding AI use.
Learning Objectives:
Attendees will understand:
- How IEC 62304 applies to AI-enabled software
- Why supplemental governance controls are needed
- Core principles of ISO/IEC 42001
- Managing AI in internal regulatory operations
- Practical governance steps for life sciences companies
Who Should Attend
- Regulatory Affairs professionals in medical devices, diagnostics, biotech, and pharma
- Quality assurance and compliance leaders
- SaMD and digital health product teams
Audience Learning Level
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email [email protected]
Speakers
