Hart, Susan


Sue Hart started out as a software engineer and architect in medical devices, and has been a director, program manager, and project manager in R&D for over 2 decades. She has also been a manager in the QA department. In her roles she has managed software, EE, and ME development as well as product V&V teams, including usability testing. Experience has been with larger industry as well as start-up businesses. Many programs have been across multiple sites, companies, and countries. Programs have been fully cross-functional, spanning all departments of an organization involved in bringing world-class multi-national new products from inception through release to market. Sue has excellent QMS Design Controls, especially Design History File experience. FDA inspection results in this area have consistently improved in terms of quality with her leadership. Recent R&D Projects have been full SDLC cloud-based using Agile methodologies.


Sue has many years of experience managing projects from inception through release to manufacturing and market sales. Projects have been fully cross-functional. She is comfortable consulting in this area. Sue also has many years of experience with 21 CFR 820.30 Design Controls and is comfortable consulting in this area, especially in regard to SOP compliance and Design History File (DHF) development.