In the purpose section of the QSPT (quality system plan template) the question of “Why?” must be answered. The purpose of this document is to ensure a quality system plan is in compliance with new and revised regulatory requirements. I think its advised to do research on existing products to learn about any new issues that happen to previous companies that had a similar device. This is a job for the project manager speaking of it. However, this document will help with preventing recurring quality issues. From MDA website it states also “maybe a faster development cycle”. This document can improve this cycle by improving the planning of these devices in coordination with speaking to manger wither operational, functional, project etc… I