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BijinV replied to the topic Benefits of this course in the forum Project Management Process and Medical Device Development 8 years, 1 month ago
This course has echoes many of the things I experience on a daily basis at the company I work for. As a small medical device company, each team member has expanded roles and responsibilities. Although I primarily work in R&D and quality, I am very often involved in regulatory meetings. Having an understanding of FDA regulations has helped me tremendously in these meetings by allowing me to define my role more clearly in assisting projects move forward. Additionally, this course has also helped me do a better job at planning and documenting the things I need for my specific functions. By having a better understanding of verification and validation procedures, I am better able to plan and meet my responsibilities.