Learn how the successful development of combination products will require great collaboration within the industry to overcome regulatory, clinical, and technical challenges.
This three-day introductory workshop provides a practical foundation for understanding the regulatory landscape governing combination products in the US, European Union, and key global markets.
This interactive four-hour workshop will teach you how PRRCs function at organizations small and large, internal or outsourced, manufacturer or authorized representative, and working with medical devices or IVDs.
This two-day interactive workshop is designed to equip regulatory and quality professionals with the essential knowledge to guide their organizations in navigating global Software as a Medical Device expectation.
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.