In this webinar, Maria Dela Vega, Director of Design at Digital Scientists, and Chandler Thames, Director of Quality at Rook Quality Systems, will guide you through the essential aspects of medical device app development and regulatory compliance. Learn why starting your design and development documentation early is crucial for success.

This session will cover:

• The typical app development process
• The importance of a solid product blueprint
• The role of user-centric design
• Identifying product classification
• Navigating premarket submission pathways
• Understanding predicate devices
• Early identification of non-clinical and clinical performance testing requirements