Associate Director Quality Compliance Combination Products
- Outlining the considerations for monitoring and maintenance of combination products throughout the entire project lifecycle
- What are the impacts of regulatory changes, marketing needs or production issues?
- The importance of developing technical documentation and supporting processes: What are the key things to include, implementation strategy and potential risks to be aware of?
- Managing change: Precisely monitoring the change control process based on the documentation
- What are the biggest challenges you are facing currently with developing and managing combination products?
- What are the unique characteristics of combination products and how does it impact the design parameters?
- What are the critical success factors for combination products? What are key requirements and success factors in selecting device manufacturing and design partners?
- How can different materials influence the design, development and compliance of combination products?
- What advice would you give in terms of testing combination products and the critical requirements for essential performance?