2025 Medcon Color Logo Fda Horz

Driving Engagement and Exploring Innovation for Medical Devices

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Presented by

Presented by AFDO RAPS Healthcare Products Collaborative

Workshop

Information about the MedCon 2025 pre-conference workshop will be announced soon. In the meantime, here are details from last year’s workshop so that you get an idea of how we will tackle vital issues.

THEME

The Device Design Change Life Cycle Experience

Experience the life cycle of a medical device design change guided by a panel of experts through interactive activities. They will help you navigate the complex pathway from initiation to implementation. Topics include change evaluation, risk management, verification/validation, 510(k) submission decisions, potential recalls and field corrections, as well as other challenges that you and your firm may encounter while implementing a medical device design change.

An overview of current and future regulatory trends in AI/ML-enabled medical devices

The impact of AI/ML on Quality and Regulatory functions

Technology, intended use, and trustworthiness challenges that the medical device industry and regulators must address

A case study walking attendees through development, submission, clearance, and deployment of an AI/ML-enabled medical device

workshop Facilitator

Bill Brodbeck

STERIS Corporation

Don’t miss this opportunity to engage with thought leaders who have had significant impact on the global discussion around this topic.

The AFDO/RAPS Healthcare Products Collaborative is a joint venture established in 2022 between the Association of Food and Drug Officials and the Regulatory Affairs Professionals Society. Learn more.

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