Medical device design for six sigma: a road map for safety and effectiveness
Gespeichert in:
| 1. Verfasser: | |
|---|---|
| Format: | Buch |
| Sprache: | English |
| Veröffentlicht: |
Hoboken, N.J.
Wiley-Interscience
2008
|
| Schlagworte: | |
| Online-Zugang: | Publisher description Contributor biographical information Table of contents only Inhaltsverzeichnis |
| Beschreibung: | Includes bibliographical references (p. 510-521) and index |
| Beschreibung: | xxvii, 528 p. ill. 25 cm |
| ISBN: | 9780470168615 0470168617 |
Internformat
MARC
| LEADER | 00000nam a2200000zc 4500 | ||
|---|---|---|---|
| 001 | BV035450267 | ||
| 003 | DE-604 | ||
| 005 | 00000000000000.0 | ||
| 007 | t | ||
| 008 | 090423s2008 xxua||| |||| 00||| eng d | ||
| 010 | |a 2007038229 | ||
| 015 | |a GBA822406 |2 dnb | ||
| 020 | |a 9780470168615 |9 978-0-470-16861-5 | ||
| 020 | |a 0470168617 |9 0-470-16861-7 | ||
| 035 | |a (OCoLC)173201722 | ||
| 035 | |a (DE-599)BVBBV035450267 | ||
| 040 | |a DE-604 |b ger |e aacr | ||
| 041 | 0 | |a eng | |
| 044 | |a xxu |c US | ||
| 049 | |a DE-860 | ||
| 050 | 0 | |a R856.6 | |
| 082 | 0 | |a 610.284 | |
| 100 | 1 | |a El-Haik, Basem |e Verfasser |4 aut | |
| 245 | 1 | 0 | |a Medical device design for six sigma |b a road map for safety and effectiveness |c Basem S. El-Haik, Khalid S. Mekki |
| 264 | 1 | |a Hoboken, N.J. |b Wiley-Interscience |c 2008 | |
| 300 | |a xxvii, 528 p. |b ill. |c 25 cm | ||
| 336 | |b txt |2 rdacontent | ||
| 337 | |b n |2 rdamedia | ||
| 338 | |b nc |2 rdacarrier | ||
| 500 | |a Includes bibliographical references (p. 510-521) and index | ||
| 650 | 7 | |a Medizinisches Gerät |2 swd | |
| 650 | 7 | |a Qualitätskontrolle |2 swd | |
| 650 | 7 | |a Six Sigma |2 swd | |
| 650 | 4 | |a Medical instruments and apparatus |x Quality control | |
| 650 | 4 | |a Medical instruments and apparatus |x Safety measures | |
| 650 | 4 | |a Six sigma (Quality control standard) | |
| 650 | 4 | |a Equipment and Supplies |x standards | |
| 650 | 4 | |a Equipment Design |x methods | |
| 650 | 4 | |a Equipment Safety |x standards | |
| 650 | 4 | |a Quality Control | |
| 700 | 1 | |a Mekki, Khalid S. |e Sonstige |4 oth | |
| 856 | 4 | |u http://www.loc.gov/catdir/enhancements/fy0804/2007038229-d.html |3 Publisher description | |
| 856 | 4 | |u http://www.loc.gov/catdir/enhancements/fy0827/2007038229-b.html |3 Contributor biographical information | |
| 856 | 4 | |u http://www.loc.gov/catdir/enhancements/fy0834/2007038229-t.html |3 Table of contents only | |
| 856 | 4 | 2 | |m HBZ Datenaustausch |q application/pdf |u http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=017370324&sequence=000006&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |3 Inhaltsverzeichnis |
| 999 | |a oai:aleph.bib-bvb.de:BVB01-017370324 | ||
Datensatz im Suchindex
| _version_ | 1804138900845756416 |
|---|---|
| adam_text | CONTENTS
Foreword xvii
Preface xix
1 Medical Device Design Quality 1
1.1 Introduction, 1
1.2 The Essence of Quality, 2
1.3 Quality Operating System and the Device Life Cycle, 5
1.3.1 Stage 1: Idea Creation, 6
1.3.2 Stage 2: Voice of the Customer and Business, 7
1.3.3 Stage 3: Concept Development, 8
1.3.4 Stage 4: Preliminary Design, 9
1.3.5 Stage 5: Design Optimization, 9
1.3.6 Stage 6: Verification and Validation, 9
1.3.7 Stage 7: Launch Readiness, 10
1.3.8 Stage 8: Mass Production, 10
1.3.9 Stage 9: Consumption, 11
1.3.10 Stage 10: Disposal or Phaseout, 11
1.4 Evolution of Quality, 11
1.4.1 Statistical Analysis and Control, 12
1.4.2 Root-Cause Analysis, 13
1.4.3 Total Quality Management, 13
1.4.4 Design Quality, 14
1.4.5 Process Simplification, 15
1.4.6 Six Sigma and Design for Six Sigma, 15
vii
viii CONTENTS
1.5 Business Excellence: A Value Proposition, 17
1.5.1 Business Operation Model, 17
1.5.2 Structure of the Medical Device Quality Function, 18
1.5.3 Quality and Cost, 22
1.5.4 Quality and Time to Market, 23
1.6 Summary, 23
2 Design for Six Sigma and Medical Device Regulation 25
2.1 Introduction, 25
2.2 Global Perspective on Medical Device Regulations, 25
2.3 Medical Device Classification, 28
2.4 Medical Device Safety, 29
2.5 Medical Device Quality Management Systems
Requirements, 31
2.6 Medical Device Regulation Throughout the Product
Development Life Cycle, 34
2.6.1 Design and Development Plan, 36
2.6.2 Design Input, 42
2.6.3 Design Output, 44
2.6.4 Design Review, 46
2.6.5 Design Verification and Validation, 47
2.6.6 Design Transfer, 49
2.6.7 Design Changes, 50
2.6.8 Design History File, 50
2.6.9 QSIT Design Control Inspectional Objectives, 51
2.7 Summary, 52
3 Basic Statistics 53
3.1 Introduction, 53
3.2 Common Probability Distributions, 53
3.3 Methods of Input and Output Analysis, 56
3.4 Descriptive Statistics, 58
3.4.1 Measures of Central Tendency, 59
3.4.2 Measures of Dispersion, 61
3.5 Inferential Statistics, 63
3.5.1 Parameter Estimation, 63
3.5.2 Hypothesis Testing, 65
3.5.3 Experimental Design, 69
3.6 Normal Distribution and Normality Assumption, 70
3.6.1 Violating the Normality Assumption, 72
3.7 Summary, 72
CONTENTS jx
4 The Six Sigma Process 73
4.1 Introduction, 73
4.2 Six Sigma Fundamentals, 73
4.3 Process Modeling, 74
4.3.1 Process Mapping, 74
4.3.2 Value Stream Mapping, 75
4.4 Business Process Management, 76
4.5 Measurement Systems Analysis, 77
4.6 Process Capability and Six Sigma Process Performance, 78
4.6.1 Motorola s Six Sigma Quality, 82
4.7 Overview of Six Sigma Improvement, 84
4.7.1 Phase 1: Define, 84
4.7.2 Phase 2: Measure, 84
4.7.3 Phase 3: Analyze, 85
4.7.4 Phase 4: Improve, 85
4.7.5 Phase 5: Control, 85
4.8 Six Sigma Gose Upstream: Design for Six Sigma, 86
4.9 Summary, 86
Appendix 4A: Cause-and-Effect Tools, 87
5 Medical Device Design for Six Sigma 89
5.1 Introduction, 89
5.2 Value of Designing for Six Sigma, 91
5.3 Medical Device DFSS Fundamentals, 94
5.4 The ICOV Process in Design, 96
5.5 The ICOV Process in Product Development, 98
5.6 Summary, 100
6 Medical Device DFSS Deployment 101
6.1 Introduction, 101
6.2 Medical Device DFSS Deployment Fundamentals, 102
6.3 Predeployment Phase, 103
6.3.1 Predeployment Considerations, 105
6.4 Deployment Phase, 125
6.4.1 Training, 126
6.4.2 Project Financials, 127
6.5 Postdeployment Phase, 128
6.6 DFSS Sustainability Factors, 129
6.7 Black Belts and the DFSS Team: Cultural Change, 132
6.8 Summary, 135
7 Medical Device DFSS Project Road Map 137
7.1 Introduction, 137
7.2 Medical Device DFSS Team, 139
x CONTENTS
7.3 Medical Device DFSS Road Map, 143
7.3.1 Phase 1: Identify Requirements, 144
7.3.2 Phase 2: Characterize Design, 148
7.3.3 Phase 3: Optimize Requirements, 151
7.3.4 Phase 4: Verify/Validate the Design, 152
7.4 Software DFSS ICOV Process, 154
7.5 Summary, 157
8 Quality Function Deployment 159
8.1 Introduction, 159
8.2 History of QFD, 160
8.3 QFD Fundamentals, 161
8.4 QFD Methodology, 161
8.5 HQQ Evaluation, 164
8.6 HQQ 1: The Customer s House, 165
8.6.1 Kano Model, 167
8.7 HQQ 2: Translation House, 170
8.8 HQQ 3: Design House, 171
8.9 HQQ 4: Process House, 171
8.10 Application: Auto 3D, 172
8.11 Summary, 175
9 DFSS Axiomatic Design Method 177
9.1 Introduction, 177
9.2 Axiomatic Method Fundamentals, 179
9.3 Introduction to Axiom 1, 183
9.4 Introduction to Axiom 2, 185
9.5 Axiomatic Design Theorems and Corollaries, 189
9.6 Application: Medication Mixing Machine, 192
9.7 Application: Axiomatic Design Applied to Design Controls, 193
9.8 Summary, 196
Appendix 9A: Matrix Review, 196
10 DFSS Innovation for Medical Devices 198
10.1 Introduction, 198
10.2 History of the Theory of Inventive Problem
Solving, 198
10.3 TRIZ Fundamentals, 200
10.3.1 Overview, 200
10.3.2 Analytical Tools, 204
10.3.3 Knowledge-Based Tools, 204
10.4 TRIZ Problem-Solving Process, 209
10.5 Ideal Final Result, 210
CONTENTS xi
10.5.1 Itself Method, 210
10.5.2 Ideality Checklist, 211
10.5.3 Ideality Equation, 211
10.6 Building Sufficient Functions, 212
10.7 Eliminating Harmful Functions, 212
10.8 Inventive Principles, 213
10.9 Detection and Measurement Concepts, 219
10.10 TRIZ Root Cause Analysis, 220
10.11 Evolution trends in Technological Systems, 221
10.12 TRIZ Functional Analysis and Analogy, 224
10.13 Application: Using Triads to Predict and Conceive
Next-Generation Products, 225
10.14 Summary, 234
Appendix 10A: Contradiction Matrix, 234
11 DFSS Risk Management Process 240
11.1 Introduction, 240
11.2 Planning for Risk Management Activities in Design
and Development, 241
11.3 Risk Assessment Techniques, 244
11.3.1 Preliminary Hazard Analysis, 245
11.3.2 Hazard and Operability Study, 245
11.3.3 Failure Mode and Effects Analysis, 245
11.3.4 Fault Tree Analysis, 246
11.4 Risk Evaluation, 248
11.5 Risk Control, 250
11.6 Postproduction Control, 250
11.7 Summary, 250
Appendix 11A: Robust Design Failure Mode and Effects
Analysis, 251
11 A.I Parameter Diagram, 252
11A.2 Robust Design FMEA Elements, 253
12 Medical Device Design for X 259
12.1 Introduction, 259
12.2 Design for Reliability, 262
12.3 Design for Packaging, 265
12.4 Design for Manufacture and Design for Assembly, 269
12.4.1 DFMA Approach, 269
12.4.2 DFMA in the ICOV DFSS Process, 271
12.4.3 DFMA Best Practices, 274
12.4.4 Example, 280
12.5 Design for Maintainability, 281
12.6 Design for Serviceability, 282
xii CONTENTS
12.6.1 DFS Guidelines, 282
12.6.2 Application: Pressure Recorder PCB Replacement, 285
12.7 Summary, 290
13 DFSS Transfer Function and Scorecards 291
13.1 Introduction, 291
13.2 Design Mapping, 292
13.2.1 Functional Mapping, 293
13.2.2 Process Mapping, 294
13.2.3 Design Mapping Steps, 297
13.3 Design Scorecards and the Transfer Function, 297
13.3.1 DFSS Scorecard Development, 299
13.3.2 Transfer Function Life Cycle, 299
13.4 Transfer Function Mathematics, 302
13.5 Transfer Function and Optimization, 306
13.6 Monte Carlo Simulation, 308
13.7 Summary, 309
14 Fundamentals of Experimental Design 311
14.1 Introduction, 311
14.2 Classical Design of Experiments, 314
14.2.1 Study Definition, 314
14.3 Factorial Experiment, 324
14.3.1 Mathematical Transfer Function, 325
14.3.2 Interaction Between Factors, 325
14.4 Analysis of Variance, 327
14.5 2k Full Factorial Designs, 332
14.5.1 Design Layout, 333
14.5.2 Data Analysis, 334
14.5.3 DOE Application, 334
14.5.4 The 23 Design, 341
14.5.5 The 23 Design with Center Points, 342
14.6 Fractional Factorial Designs, 343
14.6.1 The 23 1 Design, 344
14.6.2 Half-Fractional 2* Design, 345
14.6.3 Design Resolution, 346
14.6.4 One-Fourth Fractional 2k Design, 347
14.7 Other Factorial Designs, 349
14.7.1 Three-Level Factorial Design, 349
14.7.2 Box-Behnken Designs, 350
14.8 Summary, 350
Appendix 14A, 351
14A.1 Diagnostic Plots of Residuals, 351
14A.2 Pareto Chart of Effects, 351
CONTENTS Xiii
14A.3 Square and Cube Plots, 351
14A.4 Interaction Plots, 352
15 Robust Parameter Design for Medical Devices 353
15.1 Introduction, 353
15.2 Robust Design Fundamentals, 354
15.2.1 Robust Design and DFSS, 355
15.3 Robust Design Concepts, 357
15.3.1 Concept 1: Output Classification, 357
15.3.2 Concept 2: Quality Loss Function, 358
15.3.3 Concept 3: Signal, Noise, and Control Factors, 361
15.3.4 Concept 4: Signal-to-Noise Ratios, 362
15.3.5 Concept 5: Orthogonal Arrays, 363
15.3.6 Concept 6: Parameter Design Analysis, 365
15.4 Application: Dynamic Formulation, 368
15.5 Summary, 376
16 Medical Device Tolerance Design 377
16.1 Introduction, 377
16.2 Tolerance Design and DFSS, 378
16.2.1 Application: Imprecise Measurements, 380
16.3 Worst-Case Tolerance, 382
16.3.1 Application: Internal Pressures in Disposable
Tubing, 383
16.4 Statistical Tolerances, 388
16.4.1 Relationship of Tolerance to Process Capabilities, 389
16.4.2 Linear Statistical Tolerance, 389
16.4.3 Nonlinear Statistical Tolerance, 391
16.5 Taguchi s Loss Function and Safety Tolerance Design, 394
16.5.1 Nominal-the-Best Tolerance Design, 394
16.5.2 Smaller-the-Better Tolerance Design, 396
16.5.3 Larger-the-Better Tolerance Design, 397
16.6 High- vs. Low-Level Requirements Tolerance
Relationships, 398
16.6.1 Tolerance Allocation for Multiple Parameters, 399
16.7 Taguchi s Tolerance Design Experiment, 400
16.7.1 Application: Tolerance Design, 402
16.8 Summary, 404
17 Medical Device DFSS Verification and Validation 405
17.1 Introduction, 405
17.2 Design Verification Process, 408
17.2.1 Building a Verification Prototype, 416
xiv CONTENTS
17.2.2 Prototype Testing, 417
17.2.3 Confidence Interval of Small-Sample Verification, 418
17.3 Production Process Validation, 419
17.3.1 Device Verification Analysis, 427
17.4 Software Validation, 428
17.5 Design Validation, 429
17.6 Summary, 430
18 DFSS Design Transfer 431
18.1 Introduction, 431
18.2 Design Transfer Planning, 432
18.3 Process Control Plan, 433
18.4 Statistical Process Control, 434
18.4.1 Choosing the Control Chart, 435
18.4.2 Interpreting the Control Chart, 437
18.4.3 Taking Action, 438
18.5 Process Capability, 438
18.6 Advanced Product Quality Planning, 439
18.6.1 APQP Procedure, 440
18.6.2 Product Part Approval Process, 444
18.7 Device Master Record, 446
18.7.1 Document for Intended Employees, 449
18.7.2 Adequate Information, 451
18.7.3 Preparation and Signatures, 452
18.8 Summary, 453
19 Design Change Control, Design Review, and Design
History File 454
19.1 Introduction, 454
19.2 Design Change Control Process, 455
19.2.1 Pre- and Postdesign Transfer CCP, 455
19.3 Design Review, 457
19.4 Design History File, 459
19.5 Summary, 460
20 Medical Device DFSS Case Study 462
20.1 Introduction, 462
20.2 DFSS Identify Phase, 462
20.3 DFSS Characterize Phase, 467
20.4 DFSS Optimize Phase, 470
20.4.1 DOE Optimization Analysis, 476
20.4.2 DOE Optimization Conclusions, 476
20.4.3 DOE Confirmation Run, 479
CONTENTS xv
20.5 DFSS Verify/Validate Phase, 480
20.6 Summary, 487
Glossary: DFSS Terminology 488
Appendix: Statistical Tables 497
References 510
Index 523
|
| any_adam_object | 1 |
| author | El-Haik, Basem |
| author_facet | El-Haik, Basem |
| author_role | aut |
| author_sort | El-Haik, Basem |
| author_variant | b e h beh |
| building | Verbundindex |
| bvnumber | BV035450267 |
| callnumber-first | R - Medicine |
| callnumber-label | R856 |
| callnumber-raw | R856.6 |
| callnumber-search | R856.6 |
| callnumber-sort | R 3856.6 |
| callnumber-subject | R - General Medicine |
| ctrlnum | (OCoLC)173201722 (DE-599)BVBBV035450267 |
| dewey-full | 610.284 |
| dewey-hundreds | 600 - Technology (Applied sciences) |
| dewey-ones | 610 - Medicine and health |
| dewey-raw | 610.284 |
| dewey-search | 610.284 |
| dewey-sort | 3610.284 |
| dewey-tens | 610 - Medicine and health |
| discipline | Medizin |
| format | Book |
| fullrecord | <?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>02114nam a2200517zc 4500</leader><controlfield tag="001">BV035450267</controlfield><controlfield tag="003">DE-604</controlfield><controlfield tag="005">00000000000000.0</controlfield><controlfield tag="007">t</controlfield><controlfield tag="008">090423s2008 xxua||| |||| 00||| eng d</controlfield><datafield tag="010" ind1=" " ind2=" "><subfield code="a">2007038229</subfield></datafield><datafield tag="015" ind1=" " ind2=" "><subfield code="a">GBA822406</subfield><subfield code="2">dnb</subfield></datafield><datafield tag="020" ind1=" " ind2=" "><subfield code="a">9780470168615</subfield><subfield code="9">978-0-470-16861-5</subfield></datafield><datafield tag="020" ind1=" " ind2=" "><subfield code="a">0470168617</subfield><subfield code="9">0-470-16861-7</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(OCoLC)173201722</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-599)BVBBV035450267</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-604</subfield><subfield code="b">ger</subfield><subfield code="e">aacr</subfield></datafield><datafield tag="041" ind1="0" ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="044" ind1=" " ind2=" "><subfield code="a">xxu</subfield><subfield code="c">US</subfield></datafield><datafield tag="049" ind1=" " ind2=" "><subfield code="a">DE-860</subfield></datafield><datafield tag="050" ind1=" " ind2="0"><subfield code="a">R856.6</subfield></datafield><datafield tag="082" ind1="0" ind2=" "><subfield code="a">610.284</subfield></datafield><datafield tag="100" ind1="1" ind2=" "><subfield code="a">El-Haik, Basem</subfield><subfield code="e">Verfasser</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">Medical device design for six sigma</subfield><subfield code="b">a road map for safety and effectiveness</subfield><subfield code="c">Basem S. El-Haik, Khalid S. Mekki</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="a">Hoboken, N.J.</subfield><subfield code="b">Wiley-Interscience</subfield><subfield code="c">2008</subfield></datafield><datafield tag="300" ind1=" " ind2=" "><subfield code="a">xxvii, 528 p.</subfield><subfield code="b">ill.</subfield><subfield code="c">25 cm</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="b">n</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="b">nc</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="500" ind1=" " ind2=" "><subfield code="a">Includes bibliographical references (p. 510-521) and index</subfield></datafield><datafield tag="650" ind1=" " ind2="7"><subfield code="a">Medizinisches Gerät</subfield><subfield code="2">swd</subfield></datafield><datafield tag="650" ind1=" " ind2="7"><subfield code="a">Qualitätskontrolle</subfield><subfield code="2">swd</subfield></datafield><datafield tag="650" ind1=" " ind2="7"><subfield code="a">Six Sigma</subfield><subfield code="2">swd</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Medical instruments and apparatus</subfield><subfield code="x">Quality control</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Medical instruments and apparatus</subfield><subfield code="x">Safety measures</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Six sigma (Quality control standard)</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Equipment and Supplies</subfield><subfield code="x">standards</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Equipment Design</subfield><subfield code="x">methods</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Equipment Safety</subfield><subfield code="x">standards</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Quality Control</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Mekki, Khalid S.</subfield><subfield code="e">Sonstige</subfield><subfield code="4">oth</subfield></datafield><datafield tag="856" ind1="4" ind2=" "><subfield code="u">http://www.loc.gov/catdir/enhancements/fy0804/2007038229-d.html</subfield><subfield code="3">Publisher description</subfield></datafield><datafield tag="856" ind1="4" ind2=" "><subfield code="u">http://www.loc.gov/catdir/enhancements/fy0827/2007038229-b.html</subfield><subfield code="3">Contributor biographical information</subfield></datafield><datafield tag="856" ind1="4" ind2=" "><subfield code="u">http://www.loc.gov/catdir/enhancements/fy0834/2007038229-t.html</subfield><subfield code="3">Table of contents only</subfield></datafield><datafield tag="856" ind1="4" ind2="2"><subfield code="m">HBZ Datenaustausch</subfield><subfield code="q">application/pdf</subfield><subfield code="u">http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=017370324&sequence=000006&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA</subfield><subfield code="3">Inhaltsverzeichnis</subfield></datafield><datafield tag="999" ind1=" " ind2=" "><subfield code="a">oai:aleph.bib-bvb.de:BVB01-017370324</subfield></datafield></record></collection> |
| id | DE-604.BV035450267 |
| illustrated | Illustrated |
| indexdate | 2024-07-09T21:35:32Z |
| institution | BVB |
| isbn | 9780470168615 0470168617 |
| language | English |
| lccn | 2007038229 |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-017370324 |
| oclc_num | 173201722 |
| open_access_boolean | |
| owner | DE-860 |
| owner_facet | DE-860 |
| physical | xxvii, 528 p. ill. 25 cm |
| publishDate | 2008 |
| publishDateSearch | 2008 |
| publishDateSort | 2008 |
| publisher | Wiley-Interscience |
| record_format | marc |
| spelling | El-Haik, Basem Verfasser aut Medical device design for six sigma a road map for safety and effectiveness Basem S. El-Haik, Khalid S. Mekki Hoboken, N.J. Wiley-Interscience 2008 xxvii, 528 p. ill. 25 cm txt rdacontent n rdamedia nc rdacarrier Includes bibliographical references (p. 510-521) and index Medizinisches Gerät swd Qualitätskontrolle swd Six Sigma swd Medical instruments and apparatus Quality control Medical instruments and apparatus Safety measures Six sigma (Quality control standard) Equipment and Supplies standards Equipment Design methods Equipment Safety standards Quality Control Mekki, Khalid S. Sonstige oth http://www.loc.gov/catdir/enhancements/fy0804/2007038229-d.html Publisher description http://www.loc.gov/catdir/enhancements/fy0827/2007038229-b.html Contributor biographical information http://www.loc.gov/catdir/enhancements/fy0834/2007038229-t.html Table of contents only HBZ Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=017370324&sequence=000006&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | El-Haik, Basem Medical device design for six sigma a road map for safety and effectiveness Medizinisches Gerät swd Qualitätskontrolle swd Six Sigma swd Medical instruments and apparatus Quality control Medical instruments and apparatus Safety measures Six sigma (Quality control standard) Equipment and Supplies standards Equipment Design methods Equipment Safety standards Quality Control |
| title | Medical device design for six sigma a road map for safety and effectiveness |
| title_auth | Medical device design for six sigma a road map for safety and effectiveness |
| title_exact_search | Medical device design for six sigma a road map for safety and effectiveness |
| title_full | Medical device design for six sigma a road map for safety and effectiveness Basem S. El-Haik, Khalid S. Mekki |
| title_fullStr | Medical device design for six sigma a road map for safety and effectiveness Basem S. El-Haik, Khalid S. Mekki |
| title_full_unstemmed | Medical device design for six sigma a road map for safety and effectiveness Basem S. El-Haik, Khalid S. Mekki |
| title_short | Medical device design for six sigma |
| title_sort | medical device design for six sigma a road map for safety and effectiveness |
| title_sub | a road map for safety and effectiveness |
| topic | Medizinisches Gerät swd Qualitätskontrolle swd Six Sigma swd Medical instruments and apparatus Quality control Medical instruments and apparatus Safety measures Six sigma (Quality control standard) Equipment and Supplies standards Equipment Design methods Equipment Safety standards Quality Control |
| topic_facet | Medizinisches Gerät Qualitätskontrolle Six Sigma Medical instruments and apparatus Quality control Medical instruments and apparatus Safety measures Six sigma (Quality control standard) Equipment and Supplies standards Equipment Design methods Equipment Safety standards Quality Control |
| url | http://www.loc.gov/catdir/enhancements/fy0804/2007038229-d.html http://www.loc.gov/catdir/enhancements/fy0827/2007038229-b.html http://www.loc.gov/catdir/enhancements/fy0834/2007038229-t.html http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=017370324&sequence=000006&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
| work_keys_str_mv | AT elhaikbasem medicaldevicedesignforsixsigmaaroadmapforsafetyandeffectiveness AT mekkikhalids medicaldevicedesignforsixsigmaaroadmapforsafetyandeffectiveness |