Safe and Sound Software: Creating an Efficient and Effective Quality System for Software Medical Device Organizations

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ASQ Quality Press, 2006 - Business & Economics - 354 pages
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"This book provides information and recommendations to help regulatory affairs and quality managers, and consultants of software medical device design and development organizations, navigate the complex course of regulatory compliance, operational excellence, product quality, and customer satisfaction to create an effective and efficient quality system. Software organization executives, functional managers, and other interested coworkers can also use this book to secure a general understanding of the subject matter."--BOOK JACKET.
 

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Contents

REGULATION OF SOFTWARE
192
ESTABLISHMENT REGISTRATION
193
PREMARKET PRODUCT CLEARANCE
194
INCIDENT REPORTING REQUIREMENTS
198
DEVICE LABELING
199
QUALITY SYSTEM REGULATIONS
201
FDA AND COMPLIANCE
217
SUMMARY
218

ISO QUALITY SYSTEM STANDARDS
15
RESULTANT WEB OF REGULATORY AND QUALITY REQUIREMENTS
16
ESTABLISHING A COMPREHENSIVE QUALITY SYSTEM FOR A SOFTWARE MEDICAL DEVICE ORGANIZATION
17
Ramifications of Software Defects
21
EXAMPLES OF SERIOUS RAMIFICATIONS OF SOFTWARE DEFECTS
22
IMPACT ON CUSTOMERS
27
IMPACT ON SOFTWARE DEVELOPMENT ORGANIZATIONS
29
POTENTIAL SAFETY RAMIFICATIONS OF MEDICAL SOFTWARE DEFECTS
33
THREAT OF SMALL MEDICAL DEVICE MANUFACTURERS
35
SUMMARY
41
Software Quality
43
THE POOR STATISTICS OF SOFTWARE QUALITY
44
DEFINING QUALITY
47
DEFINING SOFTWARE QUALITY
54
SUMMARY
66
Software Design and Development
69
FAILURE TO FOLLOW REASONABLE PRACTICES
70
QUALITY CULTURE
72
SOFTWARE DESIGN AND DEVELOPMENT PROCEDURES
73
SUMMARY
139
Safety Risk Management
141
BENEFICIAL AND EFFICACIOUS USE
142
PRODUCT SAFETY RISK MANAGEMENT
154
RISK MANAGEMENT STANDARDS
184
SUMMARY
186
FDA Regulation
189
THE FDA
190
International Requirements
221
CE MARKING
222
GLOBAL HARMONIZATION
229
SUMMARY
231
ISO Quality System Standards
233
ISO 9001
234
2004
236
2003
237
SUMMARY
238
Other Compliance Requirements
241
HIPAA
242
SARBANESOXLEY ACT
243
INTEGRATION OF CONSISTENT OPERATIONAL SUBSYSTEMS
244
SUMMARY
246
Final Thoughts on Implementation
247
QUALITY ASSURANCEFIGHTING THE GOOD FIGHT
248
Software Medical Device Quality System Guidelines
251
QUALITY SYSTEM REQUIREMENTS
252
REQUIREMENT TRACEABILITY MATRIX
306
Outline of ISO 9126
321
Outline of ISO 149712000
323
Outline of the Quality System Regulations 21 CFR Part 820
325
Outline of the Requirements of ISO 90012000
327
Glossary
329
References
339
Index
347
Copyright

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