Technology Engineering for Medical Devices - A Lean Manufacturing Plant Viewpoint

Abstract: The development of software for medical device manufacturing is a delicate process from many points of view, including protection and compliance with regulations. Medical device companies must be able to develop and show that they have carried out the development process over the entire life cycle of the product. Technology development included. As medical devices are increasingly sophisticated and software development regulations are some of the causes, we discuss how both factors have influenced the process of software development in a medical device manufacturing plant. We think the approach may have negative implications around the board. We also explored the utility of Lean Software Development because process consistency is required.

Keywords: Medical Device Software, FDA, SDLC, Lean Software Development