Design Controls for the Medical Device IndustryCRC 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. Details procedures utilize |
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Saturs
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 |
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Citi izdevumi - Skatīt visu
Design Controls for the Medical Device Industry Marie B. Teixeira,Richard Bradley Ierobežota priekšskatīšana - 2002 |
Design Controls for the Medical Device Industry Marie B. Teixeira,Richard Bradley Priekšskatījums nav pieejams - 2003 |
Bieži izmantoti vārdi un frāzes
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