Accelerating Innovation: Effective Design Controls and Risk Management in MedTech

This webinar was presented live on July 25th, 2024, hosted by Rook Quality Systems and QuickVault by Veeva Systems. Kyle Rose (RookQS), Axel Strombergsson (Veeva), and Jeff Hau (Veeva) led the session, discussing best practices for developing and implementing design controls. Kyle outlined FDA and ISO guidelines, stressing the importance of early identification of test plans, particularly for software devices. Axel shared insights on efficient design control development and the role of QuickVault in speeding up the process while maintaining compliance. Jeff demonstrated QuickVault's new software release, highlighting its design controls and risk management features, followed by a Q&A session with all three presenters.