Strategies to Limit Project Timeline and Cost in Medical Devices

Developing medical devices under a quality management system for the FDA can be a complicated and subtle process with tremendous variability. The leading mitigatable risk to budget and schedule comes from minimizing the impact of change during the development process. This presentation will address common categories of change and how to minimize or even benefit from the disruption. You will learn about:

• Reordering your development to minimize work
• Tuning your QMS to support your development process   
• Deferred decisions and how ambiguity costs  
• Taking credit for design evolution