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Learn how the successful development of combination products will require great collaboration within the industry to overcome regulatory, clinical, and technical challenges.
This workshop is designed to help regulatory and product development teams successfully bring AI/ML-enabled medical devices to market. You will learn global reg. perspectives from the US FDA, EU MDR and China NMPA.
Join the NJ NY RAPS Chapter as we host a virtual session on how agencies have responded to Humanized Mouse (huMouse) justifications in practice, and how to position these models across development stages. The goal is to help attendees make better-informed decisions about when huMouse models strengthen a regulatory submission — and when they don't.
Gain confidence in implementing the EU MDR! Receive useful advice on updating your quality system, overseeing economic operators, addressing labeling, and handling technical documentation.
Join the TEAM-PRRC Annual Summit 2026 in Prague, the key European event dedicated to PRRCs (Persons Responsible for Regulatory Compliance) and regulatory affairs professionals in the medical device sector.
