Overview of fundamental elements and development steps for an effective strategy pathway including regulatory pathway for commercialization of medical product/medical device innovations; application of the basic regulations and associated requirements and enforcements for product market approval; exploration of product quality test method design requirements; understanding of the applicable regulations and standards pertaining to the design, testing, approval and marketing of medical devices. Credits 3. 3 Lecture Hours.
Overview of fundamental elements and development steps for an effective strategy pathway including regulatory pathway for commercialization of medical product/medical device innovations; application of the basic regulations and associated requirements and enforcements for product market approval; exploration of product quality test method design requirements; understanding of the applicable regulations and standards pertaining to the design, testing, approval and marketing of medical devices. Credits 3. 3 Lecture Hours.
