Project Management is core for all phases of a new product/process development life cycle.
PEI stands on the realization that the path from product vision to product launch requires:
- The ability to define the path
- The experience to see and overcome obstacles early to prevent delays
- To have a plan that’s visible showing the way from launch to the end of the path
Scope control, scheduling control, and budget control are the three legs that support a successful product/process development life cycle.
A successful program will be structured into phases that move through a success gate to build foundational blocks of success while reducing risk for each following phase all the way to production launch.
Phase structured programs facilitate key design & progress reviews with the client while maintaining the design history records essential for successful medical product/process development programs. All phases of the development program are executed under the Quality and Regulatory protocols.
PEI’s culture of Program Management is to develop a new product/process to make it work right while having the client engaged and knowledgeable on each step of their successful development process.
- Quality System compliant with ISO-13485
- Design History files
- Work Breakdown Structures for the program
- Phase Structured Program Schedule
- Risk Management
- Design Reviews
- Budget Control
- Resource Management
- Progress Reports