Regulatory affairs for biomaterials and medical devices / (Record no. 539072)
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| 000 -LEADER | |
|---|---|
| fixed length control field | 05720cam a2200577Mi 4500 |
| 001 - CONTROL NUMBER | |
| control field | ocn896853548 |
| 003 - CONTROL NUMBER IDENTIFIER | |
| control field | OCoLC |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20180529115637.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 141113t20152015enka ob 001 0 eng d |
| 019 ## - | |
| -- | 894171659 |
| -- | 897574800 |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9780857099204 |
| Qualifying information | (e-book) |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 0857099205 |
| Qualifying information | (e-book) |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| Cancelled/invalid ISBN | 9780857095428 |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| Cancelled/invalid ISBN | 0857095420 |
| 035 ## - SYSTEM CONTROL NUMBER | |
| System control number | (OCoLC)896853548 |
| 040 ## - CATALOGING SOURCE | |
| Original cataloging agency | DLC |
| Language of cataloging | eng |
| Transcribing agency | DLC |
| Modifying agency | AU |
| 049 ## - LOCAL HOLDINGS (OCLC) | |
| Holding library | Alfaisal Main Library |
| 050 #4 - LIBRARY OF CONGRESS CALL NUMBER | |
| Classification number | K3611.M45 |
| Item number | .R448 2015eb |
| 060 #4 - NATIONAL LIBRARY OF MEDICINE CALL NUMBER | |
| Classification number | QT 37 |
| 245 00 - TITLE STATEMENT | |
| Title | Regulatory affairs for biomaterials and medical devices / |
| Statement of responsibility, etc | edited by Stephen F. Amato and Robert M. Ezzell Jr. ; contributors S.F. Amato [and ten others]. |
| 264 #1 - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE STATEMENTS | |
| Place of production, publication, distribution, manufacture | Cambridge, England : |
| Name of producer, publisher, distributor, manufacturer | Woodhead Publishing, |
| Date of production, publication, distribution, manufacture | 2015. |
| 264 #4 - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE STATEMENTS | |
| Date of production, publication, distribution, manufacture | ©2015 |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT) | |
| Date of publication, distribution, etc | 2015. |
| 300 ## - PHYSICAL DESCRIPTION | |
| Extent | 1 online resource (203 pages) : |
| Other physical details | illustrations. |
| 336 ## - CONTENT TYPE | |
| Content Type Term | text |
| Content Type Code | txt |
| Source | rdacontent |
| 337 ## - MEDIA TYPE | |
| Media Type Term | computer |
| Media Type Code | c |
| Source | rdamedia |
| 338 ## - CARRIER TYPE | |
| Carrier Type Term | online resource |
| Carrier Type Code | cr |
| Source | rdacarrier |
| 490 1# - SERIES STATEMENT | |
| Series statement | Woodhead Publishing Series in Biomaterials ; |
| Volume number/sequential designation | number 79 |
| 504 ## - BIBLIOGRAPHY, ETC. NOTE | |
| Bibliography, etc | Includes bibliographical references at the end of each chapters and index. |
| 588 0# - | |
| -- | Print version record. |
| 505 0# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | Cover; Regulatory Affairs for Biomaterials and Medical Devices; Copyright; Contents; List of contributors; Woodhead Publishing Series in Biomaterials; 1 Biomaterials and their applications in medicine; 1.1 Biomaterials -- progression of the definition; 1.2 The history and future of biomaterials; 1.3 Types of biomaterials; 1.4 The major factors contributing to specific biomaterial choices; 1.5 Important parameters in the development of biomaterials and associated products; 1.6 Applications of biomaterials; 1.7 Sources of further information and advice; References. |
| 505 8# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | 2 Technical considerations for commercialization of biomaterials2.1 Introduction; 2.2 General considerations; 2.3 Regulation of risks associated with medical products; 2.4 Ensuring the safety of medical products; 2.5 Demonstrating the efficacy of biomaterials; 2.6 Specific product scenarios; 2.7 Biologically derived materials; 2.8 Understanding and complying with FDA guidelines; 2.9 Conclusion; References; 3 Regulatory strategies for biomaterials and medical devices in the USA: classification, design, and risk analysis. |
| 505 8# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | 3.1 Food and Drug Administration (FDA) regulatory categorizations and structure3.2 FDA classification of medical devices; 3.3 FDA Quality Systems Regulations (QSR) for medical device and biomaterial design control; 3.4 Medical device and biomaterial risk analysis; 3.5 Procurement and related processes; References; 4 Clinical development and endpoint strategies for biomaterialsand medical devices; 4.1 Food and Drug Administration (FDA) regulatory considerations for biomaterials; 4.2 Clinical development pathways for device-based classification. |
| 505 8# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | 4.3 Testing considerations for biomaterials clinical evaluation4.4 Clinical development pathways for biologic-based classification; 4.5 Clinical development pathways for combination product classification; 4.6 Clinical development elements required in biomaterials product evaluation in all regulatory pathways; Appendix 1: Applicable FDA guidance documents and ASTM standards for biomaterials; Appendix 2: Applicable FDA product codes and target areas for Class II biomaterials; 5 The clinical evaluation and approval threshold of biomaterialsand medical devices. |
| 505 8# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | 5.1 The clinical evaluation of biomaterials and medical devices5.2 Geographical differences in clinical evaluations; 5.3 Clinical quality assurance; 5.4 Threshold for approval; 5.5 The current regulatory landscape; 5.6 Future trends; References; 6 Supply chain controls for biomaterials and medical devices in the USA; 6.1 Introduction; 6.2 Overview of supply chain risks and mitigating activities; 6.3 Product distribution: traditional and emerging risks; 6.4 Counterfeit challenges; 6.5 Challenges relating to recalls, imports and environmental management; 6.6 Risk management system. |
| 520 ## - SUMMARY, ETC. | |
| Summary, etc | All biomaterials and medical devices are subject to a long list of regulatory practises and policies which must be adhered to in order to receive clearance. This book provides readers with information on the systems in place in the USA and the rest of the world. Chapters focus on a series of procedures and policies including topics such as commercialization, clinical development, general good practise manufacturing and post market surveillance. Addresses global regulations and regulatory issues surrounding biomaterials and medical devicesEspecially useful for smaller companies who may not emplo. |
| 590 ## - LOCAL NOTE (RLIN) | |
| Local note | Elsevier |
| Provenance (VM) [OBSOLETE] | ScienceDirect All Books |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Medical instruments and apparatus |
| General subdivision | Safety regulations. |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | TECHNOLOGY & ENGINEERING |
| General subdivision | Engineering (General) |
| Source of heading or term | bisacsh |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | TECHNOLOGY & ENGINEERING |
| General subdivision | Reference. |
| Source of heading or term | bisacsh |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Medical instruments and apparatus |
| General subdivision | Safety regulations. |
| Source of heading or term | fast |
| -- | (OCoLC)fst01014229 |
| 650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Biocompatible Materials |
| General subdivision | standards. |
| 650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Equipment and Supplies |
| General subdivision | standards. |
| 655 #7 - INDEX TERM--GENRE/FORM | |
| Genre/form data or focus term | Electronic books. |
| Source of term | local |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Amato, Stephen F., |
| Relator term | editor. |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Ezzell, Robert M., |
| Titles and other words associated with a name | Jr., |
| Relator term | editor. |
| 710 2# - ADDED ENTRY--CORPORATE NAME | |
| Corporate name or jurisdiction name as entry element | ScienceDirect eBooks. |
| 776 08 - ADDITIONAL PHYSICAL FORM ENTRY | |
| Display text | Print version: |
| Title | Regulatory affairs for biomaterials and medical devices. |
| Place, publisher, and date of publication | Cambridge, England : Woodhead Publishing, ©2015 |
| Physical description | xv, 185 pages |
| Series data for related item | Woodhead Publishing series in biomaterials ; Number 79 |
| International Standard Book Number | 9780857095428 |
| 830 #0 - SERIES ADDED ENTRY--UNIFORM TITLE | |
| Uniform title | Woodhead Publishing series in biomaterials ; |
| Volume number/sequential designation | no. 79. |
| 856 40 - ELECTRONIC LOCATION AND ACCESS | |
| Uniform Resource Identifier | <a href="http://ezproxy.alfaisal.edu/login?url=https://www.sciencedirect.com/science/book/9780857095428">http://ezproxy.alfaisal.edu/login?url=https://www.sciencedirect.com/science/book/9780857095428</a> |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) | |
| Source of classification or shelving scheme | Library of Congress Classification |
| Koha item type | eBooks |
No items available.