Medical Device Quality Assurance and Regulatory Compliance,9780824701772

Medical Device Quality Assurance and Regulatory Compliance

by ;
Edition: 1st
ISBN13: 9780824701772
ISBN10: 0824701771
Format: Hardcover
Pub. Date: 1998-08-11
Publisher(s): CRC Press
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Summary

Datex-Ohmeda, Madison, WI. Presents the basic concepts and issues of medical quality assurance and regulatory documents and provides the strategies for compliance with the requirements listed in these documents. Includes key references, tables, and drawings. For engineers, biomedical technicians, and students.

Table of Contents

Preface v
Section 1 Standards and Regulations Background 1(58)
Chapter 1 Quality Assurance and Regulatory Compliance
3(10)
1.1 Quality Assurance
3(2)
1.2 Regulation
5(2)
1.3 Standards
7(3)
1.4 Coping with Increased Quality Assurance and Regulatory Issues
10(1)
References
11(2)
Chapter 2 The FDA
13(14)
2.1 History of the FDA
14(1)
2.2 Registration and Listing
15(1)
2.3 Device Classification
16(3)
2.4 Medical Device Submissions
19(1)
2.5 Medical Device Reporting
20(1)
2.6 Quality System Regulation
21(1)
2.7 The FDA Inspection
21(1)
2.8 A Look at the Future
22(1)
References
23(4)
Chapter 3 The European Union
27(16)
3.1 European Directives
28(1)
3.2 European Standardization Bodies
29(2)
3.3 European Standards Development Process
31(3)
3.4 Other European Standards Considerations
34(1)
3.5 Conformity Assessment and Testing
35(3)
3.6 European Organization for Testing and Certification
38(1)
3.7 The NVCASE Program
39(1)
References
40(3)
Chapter 4 The Global Harmonization Task Force
43(6)
4.1 Objectives of the Task Force
43(2)
4.2 Philosophy of the Task Force
45(1)
4.3 Current Activities
45(1)
References
46(3)
Chapter 5 The Special Case for Software
49(10)
5.1 Software as a Technology
50(1)
5.2 Domestic Software Regulations
50(3)
5.3 Domestic Software Standards
53(1)
5.4 International Software Regulations
53(1)
5.5 International Software Standards
54(2)
5.6 The Move Toward One Software Standard
56(1)
References
57(2)
Section 2 Quality Systems 59(96)
Chapter 6 The ISO 9000 Series of Standards
61(18)
6.1 Origin of the ISO 9000 Standards
62(1)
6.2 The Role of the ISO 9000 Standards
62(1)
6.3 Structure of the ISO 9000 Standards
63(2)
6.4 The Requirements of the ISO 9000 Standards
65(1)
6.5 The ISO 9000 Registration Process
66(5)
6.6 Choosing a Registrar
71(1)
6.7 The Certification Audit
71(4)
6.8 ISO 9000 Costs
75(1)
6.9 ISO 9000 and the FDA
76(1)
References
77(2)
Chapter 7 ISO 9000 Requirements
79(38)
7.1 Management Responsibility
80(2)
7.2 Quality Systems
82(2)
7.3 Contract Review
84(2)
7.4 Design Control
86(4)
7.5 Document and Data Control
90(2)
7.6 Purchasing
92(3)
7.7 Control of Customer-Supplied Product
95(1)
7.8 Product Identification and Traceability
95(1)
7.9 Process Control
96(2)
7.10 Inspection and Testing
98(2)
7.11 Control of Inspection, Measuring, and Test Equipment
100(3)
7.12 Inspection and Test Status
103(1)
7.13 Control of Nonconforming Product
104(1)
7.14 Corrective and Preventive Action
105(1)
7.15 Handling, Storage, Packaging, Preservation, and Delivery
106(2)
7.16 Control of Quality Records
108(2)
7.17 Internal Quality Audits
110(1)
7.18 Training
111(1)
7.19 Servicing
112(1)
7.20 Statistical Techniques
113(2)
References
115(2)
Chapter 8 The ISO 14000 Series of Standards
117(16)
8.1 History of ISO 14000
117(2)
8.2 Purpose
119(1)
8.3 The ISO 14000 Series of Standards
120(1)
8.4 ISO 14001
120(1)
8.5 Why Certify to ISO 14001?
121(1)
8.6 Benefits of ISO 14000
121(3)
8.7 The Environmental Protection Agency's Self-Audit Policy
124(2)
8.8 The ISO 14001 Registration Process
126(1)
8.9 The ISO 14001 Audit
126(4)
8.10 ISO 14000 Costs
130(1)
8.11 Integrating ISO 14000
131(1)
References
131(2)
Chapter 9 ISO 14000 Requirements/Compliance
133(22)
9.1 General Requirements
134(1)
9.2 Environmental Policy
135(2)
9.3 Planning
137(4)
9.4 Implementation and Operation
141(7)
9.5 Checking and Corrective Action
148(4)
9.6 Management Review
152(1)
References
153(2)
Section 3 Quality Devices 155(176)
Chapter 10 EN 46001
157(4)
10.1 History of EN 46001
157(1)
10.2 Scope
157(1)
10.3 Types of Medical Devices
158(1)
10.4 General Provisions
159(1)
References
159(2)
Chapter 11 EN 46001 Requirements/Compliance
161(18)
11.1 Management Responsibility
161(1)
11.2 Quality System
162(1)
11.3 Contract Review
163(1)
11.4 Design Control
163(1)
11.5 Document and Data Control
164(1)
11.6 Purchasing
164(1)
11.7 Control of Customer-Supplied Product
165(1)
11.8 Product Identification and Traceability
165(1)
11.9 Process Control
166(4)
11.10 Inspection and Testing
170(1)
11.11 Control of Inspection, Measuring, and Test Equipment
170(1)
11.12 Inspection and Test Status
171(1)
11.13 Control of Nonconforming Product
171(1)
11.14 Corrective and Preventive Action
172(1)
11.15 Handling, Storage, Packaging, Preservation, and Delivery
173(2)
11.16 Control of Quality Records
175(1)
11.17 Internal Quality Audits
176(1)
11.18 Training
176(1)
11.19 Service
177(1)
11.20 Statistical Techniques
177(1)
Reference
178(1)
Chapter 12 The ISO 13485 Standard
179(4)
12.1 History
179(1)
12.2 Scope
179(1)
12.3 Classification of Medical Devices
180(1)
12.4 General Provisions
181(1)
12.5 Guidance Document
181(1)
References
182(1)
Chapter 13 ISO 13485 Requirements/Compliance
183(18)
13.1 Management Responsibility
183(1)
13.2 Quality System
184(1)
13.3 Contract Review
184(1)
13.4 Design Control
185(1)
13.5 Document and Data Control
186(1)
13.6 Purchasing
186(1)
13.7 Control of Customer-Supplied Product
187(1)
13.8 Product Identification and Traceability
187(1)
13.9 Process Control
188(4)
13.10 Inspection and Testing
192(1)
13.11 Control of Inspection, Measuring, and Test Equipment
193(1)
13.12 Inspection and Test Status
193(1)
13.13 Control of Nonconforming Product
193(1)
13.14 Corrective and Preventive Action
194(2)
13.15 Handling, Storage, Packaging, Preservation, and Delivery
196(2)
13.16 Control of Quality Records
198(1)
13.17 Internal Quality Audits
199(1)
13.18 Training
199(1)
13.19 Service
199(1)
13.20 Statistical Techniques
199(1)
References
200(1)
Chapter 14 IEC 601-1-4
201(14)
14.1 Scope
202(1)
14.2 General Provisions
202(1)
14.3 Risk
203(1)
14.4 Deciding on Acceptable Risk
204(1)
14.5 Factors Important to Medical Device Risk Assessment
205(3)
14.6 Risk Management
208(1)
14.7 The Risk Management Process
208(5)
References
213(2)
Chapter 15 IEC 601-1-4 Requirements/Compliance
215(16)
15.1 Documentation
215(1)
15.2 Risk Management Plan
216(2)
15.3 Development Life Cycle
218(1)
15.4 Risk Management Process
219(3)
15.5 Qualification of Personnel
222(1)
15.6 Requirement Specification
223(1)
15.7 Architecture
224(1)
15.8 Design and Implementation
225(1)
15.9 Verification
226(1)
15.10 Validation
226(1)
15.11 Modification
227(1)
15.12 Assessment
228(1)
References
228(3)
Chapter 16 ISO 9000-3
231(18)
16.1 Scope
232(1)
16.2 General Provisions
232(2)
16.3 Structure of the Standard
234(2)
16.4 Guidance within the Standard
236(10)
16.5 TickIT
246(1)
References
246(3)
Chapter 17 ISO 9000-3 Requirements/Compliance
249(40)
17.1 Management Responsibility
249(3)
17.2 Quality System
252(1)
17.3 Internal Quality System Audits
253(1)
17.4 Corrective Action
254(1)
17.5 Contract Reviews
255(2)
17.6 Purchaser's Requirements Specification
257(1)
17.7 Development Planning
258(4)
17.8 Quality Planning
262(2)
17.9 Design Control
264(2)
17.10 Testing and Validation
266(2)
17.11 Acceptance
268(2)
17.12 Maintenance
270(4)
17.13 Configuration Management
274(3)
17.14 Document Control
277(2)
17.15 Quality Records
279(2)
17.16 Measurement
281(1)
17.17 Rules, Practices, and Conventions
282(1)
17.18 Tools and Techniques
283(1)
17.19 Purchasing
283(3)
17.20 Included Software Product
286(1)
References
287(2)
Chapter 18 IEC 601-1
289(22)
18.1 History
289(2)
18.2 The Purpose of Safety Testing
291(1)
18.3 General Provisions
291(2)
18.4 Classification of Equipment
293(2)
18.5 Testing
295(13)
18.6 Proof of Compliance
308(1)
References
309(2)
Chapter 19 IEC 601-1 Requirements/Compliance
311(20)
19.1 General Requirements
312(1)
19.2 Environmental Conditions
313(1)
19.3 Protection Against Electric Shock Hazards
313(10)
19.4 Protection Against Mechanical Hazards
323(2)
19.5 Protection Against Hazards from Unwanted or Excessive Radiation
325(1)
19.6 Protection Against Hazards of Ignition of Flammable Anesthetic Mixtures
326(1)
19.7 Protection Against Excessive Temperatures and Other Safety Hazards
327(1)
19.8 Accuracy of Operating Data and Protection Against Hazardous Output
328(1)
19.9 Abnormal Operation and Fault Conditions
328(1)
19.10 Constructional Requirements
328(2)
References
330(1)
Section 4 Regulation 331(90)
Chapter 20 The Medical Devices Directives
333(8)
20.1 History
334(1)
20.2 General Provisions
334(1)
20.3 Definition of a Medical Device
335(1)
20.4 Classification of Medical Products
336(1)
20.5 Conformity Assessment Requirements
337(1)
20.6 The Medical Devices Directives Process
338(1)
20.7 Conclusion
339(1)
References
339(2)
Chapter 21 The Medical Devices Directives Requirements and Compliance
341(26)
21.1 Requirements
341(1)
21.2 Compliance
342(22)
References
364(3)
Chapter 22 Quality System Regulations
367(6)
22.1 History of the Quality System Regulations
368(1)
22.2 Scope
369(1)
22.3 General Provisions
370(1)
References
371(2)
Chapter 23 Quality System Regulations Requirements and Compliance
373(22)
23.1 Quality System
374(1)
23.2 Design Controls
375(2)
23.3 Document Controls
377(1)
23.4 Purchasing Controls
378(2)
23.5 Identification and Traceability
380(1)
23.6 Production and Process Controls
381(3)
23.7 Acceptance Activities
384(1)
23.8 Nonconforming Product
385(1)
23.9 Corrective and Preventive Action
386(1)
23.10 Labeling and Packaging Controls
387(2)
23.11 Handling, Storage, Distribution, and Installation
389(1)
23.12 Records
390(2)
23.13 Servicing
392(1)
References
393(2)
Chapter 24 FDA Submittals
395(12)
24.1 Registration
395(1)
24.2 The 510(k)
396(1)
24.3 The PMA
397(3)
24.4 The IDE
400(2)
24.5 The MDR
402(2)
24.6 Advisory Notices and Recalls
404(2)
References
406(1)
Chapter 25 FDA Submittal Requirements and Compliance
407(14)
25.1 Registration
407(2)
25.2 The 510(k)
409(5)
25.3 The PMA
414(1)
25.4 The IDE
415(1)
25.5 The MDR
416(2)
25.6 Recalls
418(2)
References
420(1)
Section 5 Appendices 421(52)
Appendix 1 Addresses of Standards Organizations
423(8)
Appendix 2 Addresses of Quality System Registrars/Notified Bodies
431(8)
Appendix 3 Addresses of Regulatory Agencies
439(4)
Appendix 4 Addresses of FDA Offices
443(2)
Appendix 5 Addresses of Consulting/Training Organizations
445(8)
Appendix 6 Addresses of Testing Organizations
453(4)
Appendix 7 Glossary
457(16)
Index 473

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