Sponsored Webcast: Doing More with Less: How AI-Powered CER Workflows Are Transforming MDR Compliance and Notified Body Readiness

Medical device regulatory teams are under growing pressure to maintain EU MDR compliance while managing expanding product portfolios, evolving clinical evidence requirements, and continued Notified Body scrutiny. This webinar explores how organizations can move beyond document-centric Clinical Evaluation Report (CER) processes and adopt AI-enabled workflows that improve quality, traceability, consistency, and operational efficiency while maintaining expert regulatory oversight. Drawing on both regulatory practitioner experience and real-world implementation insights, the session will examine how AI can support CER development, evidence management, and regulatory knowledge retention while keeping human judgment at the center of critical compliance decisions. Attendees will gain practical insights into building more scalable CER workflows and improving MDR compliance and Notified Body readiness.

Learning Objectives

Upon completion of this webinar, attendees will be able to:

Identify key challenges affecting CER efficiency, quality, and MDR compliance.
Understand where AI can safely support CER development and evidence management workflows.
Evaluate approaches for improving traceability, consistency, and Notified Body readiness. - Recognize the operating model changes needed to successfully adopt AI-enabled CER workflows.
Apply best practices for maintaining human oversight and regulatory defensibility when using AI-assisted processes.

Who Should Attend

VPs, directors, managers, and regulatory affairs professionals responsible for Clinical Evaluation Reports (CERs), MDR compliance, clinical evidence generation, regulatory operations, technical documentation, and Notified Body readiness. The program is also relevant for regulatory leaders evaluating AI-enabled approaches to improve efficiency, traceability, and scalability within regulatory workflows

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.