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学术期刊
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学术著作
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International Medical Research and Translation (IMRT) June 2026, Vol.2, No.3
Analysis of the Construction of a Quality Management System for Medical Device Manufacturing
Bin Gao
Shanghai Microport EP MedTech Co., Ltd., Shanghai 201038, China
Abstract: Driven by the rapid expansion of the medical and health sector alongside increasingly strict regulatory supervision standards, the conventional quality control operation mode adopted by medical device manufacturers can no longer match the industry’s high-standard development targets. To resolve prominent drawbacks including fragmented full-chain quality supervision and delayed risk disposal response in device production procedures, this paper first elaborates the practical value of quality control work for medical device production from two dimensions: industrial sustainable growth and clinical patient safety, and clarifies that building a standardized and scientific quality management framework serves as the core guarantee for stable industrial progress. Combined with the unique production characteristics of medical devices, this paper sorts out prominent bottlenecks existing in current enterprise quality management frameworks, covering document system construction, real-time production supervision, raw material lifecycle control and adverse incident disposal mechanisms. Corresponding targeted improvement strategies are put forward to realize refined risk control covering all links of medical device production, and boost the systematicity and operability of internal enterprise quality management frameworks.
Keywords: medical device production, quality management system, documentation system, production, materials
