James Wabby (Executive Director, Regulatory Affairs, Devices and Combination Products, Allergen)
Janet Michener Whipple (Partner, Medical Devices and Invitro-Diagnostics, Validant)
Date: Thursday, February 7
Time: 8:30am - 10:00am
MD&M West: Product Development & User-Centered Design
Vault Recording: TBD
When it comes to developing medical devices, the ends don’t always justify the means. Your device might be innovative, but if it’s difficult or too costly to produce, it may never get off the ground. Design and product development engineers will come away from this session with key takeaways about transferring a product to manufacturing and why it is important to plan early for manufacturing processes.
Topics covered include:
- Concurrent engineering and use of the risk management processes to determine critical control points
- How to use a risk-based approach for inspection and testing
- An example of a design transfer checklist, as well as methods for tracking completion of all design transfer activities
- Challenges and opportunities going from design validation to completion of design transfer
For more information about: VALIDANT | Vital in healthcare; visit www.validant.com.