摘 要
当今社会中经济水平日益提升，科技水平也在不断进步，人们的生活质量也不断提高，对于健康问题也越来越注重，这也使有关医疗方面行业日渐增多。随着医疗事业的发展，人们对于疾病的研究治疗等方面的技术也越来越多，医疗器械的出现对医学研究起到重要作用。随着医疗器械广泛的运用，其类型技术也不断的更新，那么对于医疗器械的质量也有着严格要求。针对医疗器械要具有有效的特性，其主要源于产品的开发设计，那么对这一阶段的管理可以影响到产品的以后的经济效益，有利于产品在以后的生产、运用等过程中的风险降到最低，减少病人使用产品过程中带来不必要的伤害。
本文是以A医疗器械设备公司为例，针对其公司中DL产品的研发阶段中，对其研发过程的质量管理进行分析研究，并通过质量设计的计划、风险的管理、产品过程的应用等方面的分析提出相应的方法和举措，详细研究记录过程的详情和现状，通过详加分析研究，透过现象看本质，透过问题看规律，并对问题改善前与改善后的现象进行比较，总结规律最后得出能够实用的规律。本文将采用案例研究的方式，以A医疗器械设备公司DL产品设计开发项目的质量管理为研究对象，介绍 PDCA、质量控制计划、风险管理、过程确认、质量功能展开、失效模式分析等改进的措施和工具，描述DL医疗器械产品在设计开发阶段质量管理的现状和过程，通过总结DL产品设计开发的质量管理存在的问题和分析，对产品设计开发的质量管理提出改进措施和对改进前后进行效果对比。
本文在此研究过程中所使用的方法技巧，并且对所开发设计产品过程中出现的问题进行分析和研究，提出观点和解决措施，这对A公司的研发过程以及质量的管理具有一定的指导意义，还可将其提供给同行业的产品开发者进行应用参考。
关键词：质量管理；质量控制计划；过程确认；风险管理；质量功能展开
ABSTRACT
With the development of the world's economy, science and technology, humans satisfy the material and spiritual needs at the same time, more and more attention to their own health, more and more resources to the health care industry. Discovered only in recent decades relied on drugs do not respond to disease research, diagnosis, prevention, monitoring, treatment and replacement human tissue, support or sustain life, and began to appear and the rapid development of medical devices. From scratch, improving, medical devices have different characteristics of the product with other products requiring a safe and effective. This means medical devices quality management focused on product design and development stages. Quality management in medical device design and development phase, product manufacture in the future, listing, sale, use and play a decisive role in the recovery process can improve the economic efficiency of enterprises, can predict and control products in the manufacture, sale and use of risk, reducing harm to patients.
Paper will used case research of way, to a, medical equipment limited DL products design development project of quality management for research object, introduced PDCA, and quality control plans, and risk management, and process confirmed, and quality function expand, and failure mode analysis, improved of measures and tool, description x medical devices products in design development stage quality management of status and process, through summary DL products design development of quality management exists of problem and analysis, On the design and development of products quality management improvement measures and the comparison of before and after improvement. This paper used case research of way, to a, medical devices equipment company DL products design development project of quality management for research object, introduced PDCA, and quality control plans, and risk management, and process confirmed, and quality function expand, and failure mode analysis, improved of measures and tool, description DL medical devices products in design development stage quality management of status and process, through summary DL products design development of quality management exists of problem and analysis, On the design and development of products quality management improvement measures and the comparison of before and after improvement.
Based on DL quality management problems of product design and development analysis and improvement measures for a medical equipment company limited design and development, quality control capabilities and continuous improvement are important, but also for the medical device industry quality management of new product design and development company providing information and reference.
KEYWORDS：Quality management；The quality control plan；Process validation；Risk management；Quality function deployment
目 录
摘 要 I
ABSTRACT II
目 录 1
第一章 绪论 1
1.1 研究与背景与意义 1
1.2 国内外研究现状 3
1.3 本文研究内容 7
第二章 产品设计质量管理理论 8
2.1 产品设计质量的定义 8
2.2 产品设计质量的内涵 9
2.2.1产品的功能 9
2.2.2产品的性能 11
2.3影响设计质量的主要因素 12
2.4用户需求分析 13
2.4.1建立用户需求的AHP模型 13
2.4.2确定用户需求重要度 15
2.5产品设计质量特征的提取 16
2.5.1 建立用户需求与设计质量特征的关系表 17
2.5.2基于质量屋技术提取产品设计质量特征 18
第三章 DL产品设计开发质量管理存在的问题分析 21
3.1 A医疗设备有限公司质
