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.
Learn how the successful development of combination products will require great collaboration within the industry to overcome regulatory, clinical, and technical challenges.
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.
