Design Controls for the Medical Device Industry

Pirmais vāks
CRC Press, 2002. gada 20. sept. - 254 lappuses
This reference 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-offering product development models for the production of safe, durable, and cost-efficient medical devices and systems.

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Overview AN IDEA IS BORN
1
ASK THE CUSTOMER
2
DESIGN CONTROLS AND THE FDA
3
DESIGN CONTROLS AND REALITY
4
DESIGN CONTROLS AND THE BOTTOM LINE
5
DESIGN CONTROLS AND THE CUSTOMER
7
Design and Development Planning
11
WHATS A PLAN?
13
Design Validation
89
THE FDA AND VALIDATION
90
TYPICAL VALIDATION ACTIVITIES
92
COMMON RISK ANALYSIS TOOLS
93
RISK ASSESSMENT OF MEDICAL DEVICE MATERIALS
99
BIOCOMPATIBILITY
102
REGULATORY ASPECTS OF BIOCOMPATIBILITY
104
PHASES OF BIOCOMPATIBILITY TESTING
107

THE FDA DESIGN CONTROLS AND PLANS
14
PLANNING TECHNIQUES
16
ARE PROJECTS REALLY ALWAYS LATE AND OVERBUDGET?
19
Design Input I INPUT WHO NEEDS INPUT?
25
THE FOUNDATIONDESIGN INPUT
27
THE IMPORTANCE OF DESIGN INPUT AND FDA REQUIREMENTS
28
THE CONCEPT DOCUMENT
29
PRODUCT PERFORMANCE SPECIFICATION
31
Design Input II TO DESIGN CONTROL OR NOT TO DESIGN CONTROL
35
PERFORMANCE CHARACTERISTICS
36
PRODUCT CHARACTERISTICS
42
MARKET REQUIREMENTS
46
REGULATORY AND QUALITY ASSURANCE AND CONTRACTUAL REQUIREMENTS
47
Design Outputs
49
THE FDA AND DESIGN OUTPUTS
50
THERE MUST BE AN END
51
DESIGN OUTPUT REQUIREMENTS
53
THE DEVICE MASTER RECORD
55
Design Review NOT ANOTHER MEETING
59
THE FDA AND DESIGN REVIEWS
60
DESIGN REVIEW REQUIREMENTS
61
DESIGN REVIEW FOCUS
62
DESIGN REVIEW STAGES
63
MEETING DYNAMICS
66
Design Verification
77
THE FDA AND DESIGN VERIFICATION
78
TYPICAL VERIFICATION ACTIVITIES
79
RISK MANAGEMENT
80
HUMAN FACTORS
85
RISK MANAGEMENT DOCUMENTATION
86
TESTS TO DEMONSTRATE BIOCOMPATIBILITY
111
Process Validation
123
THE FDA AND PROCESS VALIDATION
124
WHAT DO YOU CALL A GROUP OF PROCESSES?
125
STATISTICAL PROCESS CONTROL
130
Design Transfer
137
CHECK YOUR ATTITUDE AT THE DOOR
138
THE FDA AND DESIGN TRANSFER
140
DESIGN TRANSFER REQUIREMENTS
141
Design Changes
143
THE FDA AND DESIGN CHANGES
144
THE DOCUMENT CHANGE REQUEST
146
The Design History File
147
THE FDA AND THE DESIGN HISTORY FILE
148
Questions to Expect in an Audit
151
SOME QUESTIONS YOU MAY BE ASKED
153
Further Reading
157
Implementation Procedure
161
Concept Document
175
Product Specification
179
Product Claims Sheet
191
Risk Analysis Standard Operating Procedure
193
CauseandEffects Diagram
205
Validation Procedure
209
Material Specification
221
Quality Specification
225
Design Change Procedure
227
Index
239
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