Project Plan

After we complete the Concept Generation phase, our program management team creates a detailed project plan and estimates for further work. We leverage our experience to create a customized plan defining clear and relevant milestones for each program. We outline further development work on the device and provide a roadmap for commercialization.

Development Plan

Our program management team creates a development plan describing tasks and the development schedule with key milestones and resources. We describe all work in the development plan and begin generating design inputs, which we summarize in a traceability matrix. We consider a mutually agreed-upon responsibility matrix an essential part of the plan.

Reporting

At the end of the Verification & Validation phase, our program management team leads a final design review to verify that we have met all design requirements, closed all risk management items, and completed all tasks in the development plan, risk plan, verification plan, and validation plan. We complete the device master record (DMR) and device history record (DHR).

Documentation

Our program management team controls all documentation in a project file or a design history file, depending on the quality system we use to control development. We conduct a phase-end design review to review all tasks against the development plan and ultimately release all documentation into the quality system.