Design Verification Proposal: Food and Drug Administration _______________________________________________________________________________________________________ _______________________________________________________________________________________________________ ______________ Objective To correctly map a biomedical product through development and write a proposal to the FDA for mock approval. Additionally, to familiarize ourselves with specific FDA guidelines and regulations. Target Requirements 1) Overview current drug eluting and non-bio absorbing stents 2) Highlight advantages of bio absorbing stents 3) Timeline a development plan 4) Highlight 6-12 month service and bio absorbing time 5) Overview preliminary testing of different PHs and body conditions 6) Highlight contingency plan if material does not correctly form into correct geometries for testing Timeline overview of Ghantt Chart tasks and completion dates Results Initial peer rejection due to lack of depth within contingency plan and polymer forming Recommendations In the future identify critical paths in the project scope and address those critical paths