In the planning phase of a medical device, some more aspects that should be discussed are: stakeholders, roles and responsibilities, scope, schedule and cost, management plan, staffing plan, quality and risk. These are some very important terms to discuss in the planning phase. Roles and responsibilities include project sponsors, project team, managers and business experts. Each of these play key roles in the initiation of a project. A scope helps define the project plan and clearly portrays how large or small of a project this will be. It also helps identify “all the deliverables produced on the project, and therefore, identifies all the work to be done.” Schedules help keep the project on a timeline and cost helps verify that there’s enough funding for the kickoff and maintenance of a project. Quality and risks include putting forth acceptance criteria that will help define checkpoints for the project.