Examining the Design Output Phase of medical device and combination product development. How can we integrate Risk Management activities to ensure a safe and effective final product? Can we take steps to ensure a smoother transition into the verification and validation phase?
Key Topics Covered:
- Integration with Risk Management – How Failure Modes and Effects Analysis (FMEA) and Use Related Risk Analysis (URRA) help identify risks and drive additional risk controls or design inputs.
- Design Freeze & Pre-Design Verification – The importance of finalizing designs before full-scale verification, including engineering study loops to refine product performance.
- Verification & Validation (V&V) Planning – Ensuring all necessary test protocols, acceptance criteria, and compliance strategies are in place to streamline regulatory approvals.
Are you working with a drug delivery device and are interested in more information regarding Essential Drug Delivery Outputs (EDDOS)? Check out our blog on FDA Draft Guidance for EDDOs;
Find it here: https://ventura-solutions.com/fda-guidance-essential-drug-delivery-overview/ on our website:
This video examines the Design Output phase for medical device and combination product development, with practical ways to integrate Risk Management to ensure a safe, effective final product and a smoother transition into Verification & Validation. Key topics include how FMEA and Use-Related Risk Analysis (URRA) drive risk controls and design inputs; Design Freeze and pre-design verification with engineering study loops to refine performance; and V&V planning to establish protocols, acceptance criteria, and compliance strategies that streamline regulatory approvals. For drug delivery teams, see our blog on FDA Draft Guidance for Essential Drug Delivery Outputs (EDDOs).
