When should we start preparing for Design Verification? What is the best way to Validate this user need? Join me as I help to answer these questions as we examine the Verification, Validation, and Post-Market Phases of the Development Process.
Key Topics Covered:
- Verification & Validation (V&V) – What is verification and validation? Why are they important to patient safety and developing a great product?
- Test Method Validation and Designing Test Fixtures – This can be a time-consuming process; start early in developing test methods and fixtures for your requirement.
- Design Transfer – The DMR documentation and determining ideal processes for manufacture
- Post-Market Surveillance – How will you handle complaints and trace them into your existing risk management documentation?
Wether you are integrating with an off-the-shelf product or involved in novel development, understanding the development process is essential in bringing safe and effective products to market. If you are interested in more information regarding this engineering approach to device and combination product development, check out our blog.
Find it here: https://ventura-solutions.com/v-diagram-for-combination-products/on our website:
This video explores key development phases in medical device and combination product development, focusing on Verification, Validation, and Post-Market activities. Learn when to start preparing for Design Verification, how to validate user needs, and why Verification & Validation are essential to patient safety and product success. Topics covered include test method validation, designing test fixtures, design transfer, DMR documentation, and post-market surveillance processes. Perfect for teams working with novel devices or integrating off-the-shelf products, this guide provides practical insights into safe and effective product development.
