How to design and develop a Medical Device

By the end of this class you should have an understanding of the basic steps involved in Designing and Developing a Medical Device. (E.g. Class 2) You will learn about the key technical milestones, go / no go points that confirm your progress towards commercialization. You will also learn about the basics of FDA's Quality System Regulation and understand how they safeguard you as a inventor and ultimately the patient. Instructor: Sujit Tatke Sujit has worked in Med Devices for 20 years as an engineer and as a program manager in various capacities including R&D, Operations and Quality Systems. He is passionate about helping people understand the basics of the industry esp. how products are designed and developed. His goal is to demystify this process so that innovative patient centric solutions can continue to enter the marketplace sooner.