Preliminary Report
A brief overview of the project background, detailed need statement and project scope, discussion of stakeholders, and details regarding existing solutions. The complete design specifications are outlined, and project management is highlighted.
Progress Report
Updated design specifications, brainstorming of potential solutions, and Pugh Chart analysis. The final solution is chosen.
Verification & Validation Report
Final plans for verification and validation testing of the beta prototype as well as information regarding the appropriate FDA process.
Safety Hazard Analysis
All users associated with manufacturing, distributing, and using the device; the tasks each user performs; the safety hazards associated with each task; and the risk mitigation strategies for each hazard.
Final Report
Overview of the current prototype, verification and validation testing results, manufacturing and user manuals, and future steps for the project.