医疗器械 设计开发控制指南

Design Controls For The Medical Device Industry

内容介绍

Design Controls for the Medical Device Industry provides real-world examples, strategies, and templates for the implementation of effective design control programs that meet current ISO 9000 and FDA QSR standards and regulations. It also offers product development models for the production of safe, durable, and cost-efficient medical devices and systems. The book details procedures utilized by leading companies to successfully meet FDA and end-user requirements, manufacture high-quality products, and improve and generate profit. It presents blueprints for the application, evaluation, and refinement of quality assurance and performance practices, from product launch through engineering and assembly.

医疗器械行业的设计控制提供了现实世界的示例、策略和模板，用于实施符合当前 ISO 9000 和 FDA QSR 标准和法规的有效设计控制程序。 它还提供用于生产安全、耐用和具有成本效益的医疗设备和系统的产品开发模型。 这本书详细介绍了领先公司成功满足 FDA 和最终用户要求、制造高质量产品以及改进和产生利润的程序。 它提供了从产品发布到工程和组装的应用、评估和改进质量保证和性能实践的蓝图。

内容目录

目录 

第一章简介........................................................1

第二章医疗器械分类................................................3

第三章设计控制概述................................................6

适用性...................................................................6

设计控制及底线...........................................................6

何时应考虑设计控制？.....................................................7

除了明显的授权之外，设计控制还有什么好处？...............................8

诞生一个想法.............................................................8

询问客户.................................................................9

设计控制和客户...........................................................9

设计开发的阶段...........................................................9

第一阶段：定义-如：设计输入.........................................10

第二阶段：开发输出-如：设计开发输出.................................12

第三阶段：设计验证..................................................12

第四阶段：设计确认..................................................13

第五阶段：产品上市..................................................13

第六阶段：改进和优化................................................14

第四章设计开发计划...............................................15

我们是否真正需要一个计划？..............................................15

设计和开发策划要求......................................................16

设计开发计划中的关键元素................................................19

规划技术................................................................20

甘特图..............................................................20

什么时候是使用甘特图的好时机？......................................20

什么时候甘特图不合适？..............................................21

计划评审技术（PERT）图..............................................23

使用PERT有什么好处？...............................................23

什么时候PERT不合适？...............................................23

项目规划——如何开始？..................................................25

第五章设计输入：I部分............................................26

概念文档................................................................26

设计输入................................................................27

什么是设计输入？........................................................29

设计输入需求............................................................29

设计输入来源于哪里？....................................................31

如何将设计输入文件化？..................................................32

第六章设计输入：II部分...........................................34

性能特征-如用户需求.....................................................34

预期用途............................................................34

临床使用流程........................................................36

相关使用设置/环境...................................................36

用户的医学专业......................................................37 

患者群体——纳入/排除准则...........................................37

用户界面/人体工程学考虑.............................................37

产品特性——即产品需求..................................................39

物理特征............................................................40

化学特征............................................................40

生物学特征..........................................................42

测试项目的选择......................................................43

环境特征............................................................44

运输和储存..........................................................44

使用环境............................................................45

灭菌和无菌屏障特征..................................................46

灭菌方法............................................................46

无菌工艺............................................................46

可重复使用的医疗器械................................................47

包装和标签特征......................................................48

器械接口特点........................................................50

安全可靠特性........................................................53

营销要求................................................................53

目标市场............................................................54

合同要求............................................................54

声明................................................................54

标签要求............................................................56

专利、商标和许可协议................................................56

临床资料............................................................58

监管和质量保证要求......................................................58

器械分类............................................................58

器械批准的要求......................................................59

相关监管或协调标准..................................................59

标签................................................................59

合同协议............................................................60

财务要求................................................................60

设计规格................................................................60

题外话..................................................................61

第七章设计输出...................................................62

设计输出要求............................................................63

典型设计输出............................................................64

器械主记录..............................................................64

第八章设计评审...................................................67

不只是一个会议而已！....................................................67

FDA和设计评审..........................................................67

设计评审要求............................................................67

设计团队成员............................................................68

设计评审重点............................................................69

设计评审元素............................................................69 

设计评审会议............................................................70

阶段1——设计输入阶段评审..........................................71

阶段2——设计和开发阶段评审........................................72

阶段3——设计验证阶段评审..........................................72

阶段4——设计验证阶段评审..........................................73

阶段5——设计发布和销售批准（即产品发布）..........................74

阶段6——使用设计评审会议..........................................75

记录设计评审............................................................75

会议动态................................................................75

沟通技巧............................................................76

他们得到了吗？......................................................76

聆听并验证..........................................................77

接受坏消息..........................................................78

监测和测量..........................................................78

不要将提案与行动混为一谈............................................78

会议记录............................................................79

做出解决问题的决定..................................................79

第九章设计验证...................................................82

设计验证的目的是什么？..................................................82

什么是设计验证？........................................................82

设计验证—定义..........................................................82

设计验证要求............................................................82

设计验证过程............................................................83

验证活动................................................................83

建议....................................................................86

第十章风险管理...................................................87

为什么？................................................................87

风险管理如何适应设计和开发..............................................87

什么是风险管理？........................................................89

风险管理过程............................................................89

风险分析................................................................90

人为因素和风险管理过程..................................................91

风险评估................................................................93

风险控制................................................................94

风险评审................................................................96

生产后风险管理..........................................................97

第十一章设计确认.................................................98

为什么确认？............................................................98

什么是设计确认？........................................................98

设计确认的要求..........................................................98

设计确认过程...........................................................101

确认活动...............................................................103

设计确认结果...........................................................103

医疗器械材料及成品的风险评估...........................................103 

第十二章生物相容性..............................................105

作用时间...............................................................105

侵入性程度.............................................................106

生物学效应/终点........................................................106

生物相容性测试注意事项.................................................108

生物相容性测试项目.....................................................114

生物相容性测试阶段.....................................................115

筛选实验...............................................................116

全身毒性...............................................................116

细胞毒性和细胞培养.....................................................117

使用提取物评价.........................................................118

直接接触评价...........................................................118

间接接触评价...........................................................119

USP生物学测试.........................................................119

刺激试验...............................................................120

致敏测试...............................................................120

血液相容性测试.........................................................121

植入测试...............................................................122

诱变测试（基因毒性）...................................................123

补充测试...............................................................124

致癌性测试.............................................................124

生殖和发育毒性.........................................................125

生物降解...............................................................125

第十三章设计转移................................................127

设计转移的重要性.......................................................127

设计转化需求...........................................................128

设计转移...............................................................128

设计转移检查表.........................................................129

设计放行...............................................................129

第十四章设计变更................................................131

为什么要控制设计变更...................................................131

设计变更举例...........................................................131

设计变更需求...........................................................132

设计变更程序...........................................................133

设计变更评估...........................................................133

设计变更记录...........................................................134

第十五章设计历史文档............................................136

我们为什么需要设计历史文档.............................................136

什么是设计历史文档.....................................................136

设计历史文档的要求.....................................................136

设计历史文档要素.......................................................136

第十六章FDA检查指南.............................................139

噢,不!FDA调查员来了...................................................139

总体设计控制要求.......................................................139 

设计和开发计划.....................................................139

设计输入...........................................................139

设计输出...........................................................140

设计评审...........................................................140

设计验证...........................................................141

设计确认...........................................................141

设计转移...........................................................142

设计变更...........................................................142

设计历史文档.......................................................142

附录A：设计控制程序..............................................143

附录B：设计输入文档..............................................157

附录C：产品声明表................................................159

附录D：输入/输出设计跟踪矩阵.....................................160

附录E：项目审批表................................................162

附录F：设计阶段评审会议记录......................................163

附录G：风险分析..................................................167

附录H：临床评估报告..............................................173

附录I：设计转移清单..............................................177

附录J：设计变更表................................................179

附录K：批准销售表格..............................................180

附录L：工程变更单................................................181

医疗器械 设计开发控制指南（Design Controls For The Medical Device Industry）