Construction Practice of Medical Device Product Life Cycle Management Platform

Abstract

Medical device product life cycle management is one of the core contents of medical device quality management system construction, spanning the entire process of enterprise core business activities including market, research and development, procurement, production, and services. Building a comprehensive and efficient life cycle management system facilitates the implementation of quality management systems. Taking the example of the construction of a unified product life cycle management platform for medical device hardware and software that has been launched and operated, this article describes the general principles and practical experience of constructing a medical device life cycle management platform, including requirements collection, system design, product selection, customization development and confirmation, as well as platform trial, acceptance commissioning, and operation and maintenance management.