[Life Cycle Risk Analysis and Key Technical Points of Quality Management System Certification for Digital Surgical Suction System].

The digital surgical suction system integrates Intelligent digital technologies, features rapid iterations, and has complex components and high control accuracy requirements, which puts forward higher requirements for product quality control and medical device quality management system certification. This study puts forward the key points for quality management system certification in manufacturing of such products through the analysis of the technical characteristics and product life cycle risk of digital surgical suction system, combined with the requirements of ISO 13485:2016 medical device quality management system for regulations. It has certain reference significance for the quality management of enterprises and the medical device quality management system audit of certification bodies.