Manager, Device Engineering
- 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?
•Defining each term, meaning and relevance
•Ensuring adequate input into the risk management process during product development to identify potential issues
•Developing processes and activities used to continually monitor and evaluate the safety and performance of combination products
•Reporting procedures: Who, what, when and how?