| Description |
1 online resource : color illustrations |
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text txt rdacontent |
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computer c rdamedia |
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online resource cr rdacarrier |
| Series |
Woodhead Publishing series in biomaterials ; number 103 |
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Woodhead Publishing series in biomaterials ; no. 103.
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| Note |
Online resource; title from PDF title page (EBSCO, viewed August 21, 2015). |
| Bibliography |
Includes bibliographical references and index. |
| Summary |
Medical Devices and Regulations: Standards and Practices will shed light on the importance of regulations and standards among all stakeholders, bioengineering designers, biomaterial scientists and researchers to enable development of future medical devices. Based on the authors' practical experience, this book provides a concise, practical guide on key issues and processes in developing new medical devices to meet international regulatory requirements and standards. |
| Contents |
Front Cover -- Medical Devices: Regulations, Standards and Practices -- Copyright -- Contents -- List of contributors -- Woodhead Publishing Series in Biomaterials -- Chapter 1: Introduction -- 1.1. Medical devices: definitions and types -- 1.2. Market trend -- 1.3. Safety issues -- 1.4. The development of regulations and standards -- 1.5. The structure of this book -- FAQs -- Part One: Regulations and standards -- Chapter 2: General regulations of medical devices -- 2.1. Introduction -- 2.2. The United States |
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2.2.1. The regulatory authority for medical devices and its organization in the United States2.2.2. Classification of medical devices and the relevant controls in the United States -- 2.2.3. Practical guide to identifying the medical devices classification in the United States -- 2.3. The European Union -- 2.3.1. Regulatory framework for medical devices in the EU -- 2.3.2. New changes in EU regulation -- 2.3.3. Differences between the regulations for medical devices in the United States and the EU -- 2.4. China |
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2.4.1. The regulatory framework for medical devices in China2.4.2. Changes in Chinese regulations -- 2.4.2.1. The evolution of CFDA -- 2.4.2.2. Revised regulation on the supervision and administration of medical devices -- 2.5. Japan -- 2.6. Australia -- 2.7. India -- 2.8. Singapore -- 2.8.1. Regulatory framework for medical devices in Singapore -- 2.8.2. Grouping of medical devices for production registration in Singapore -- 2.9. Conclusions -- FAQs -- Chapter 3: Quality management systems for medical device manufacture -- 3.1. Introduction |
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3.1.1. History of QSR 21 CFR 8203.1.2. History of ISO 13485 -- 3.2. ISO 13485:2012 -- 3.2.1. General requirements of ISO 13485: 2012 -- 3.2.2. Document control required by ISO 13485:2012 -- 3.2.2.1. Quality manual -- 3.2.2.2. Control of documents -- 3.2.2.3. Control of records -- 3.2.3. Processes required by ISO 13485 -- 3.2.3.1. Implementation -- 3.2.3.2. Process effectiveness -- 3.2.4. Conformity assessment, registration, and certification processes -- 3.2.4.1. Conformity assessment -- 3.2.4.2. Certification |
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3.2.5. ISO 13485 application in various countries3.2.5.1. EU -- 3.2.5.2. Canada -- 3.2.5.3. Japan -- 3.3. Current good manufacturing practice -- 3.4. The difference between ISO 13485 and cGMP -- 3.5. Conclusions -- FAQs -- Chapter 4: The process of gaining approval for new medical devices -- 4.1. Introduction -- 4.2. The United States -- 4.2.1. Step 1: Classify device -- 4.2.2. Step 2: Choose correct premarket submission -- 4.2.3. Step 3: Prepare documents for submission to the FDA -- 4.2.3.1. Class I process -- 4.2.3.2. Class II process-510(k) |
| Subject |
Medical instruments and apparatus.
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Surgical instruments and apparatus.
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Equipment and Supplies -- standards |
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Equipment and Supplies |
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Surgical Equipment |
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Surgical Instruments |
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Médecine -- Appareils et instruments.
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Chirurgie -- Appareils et matériel.
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HEALTH & FITNESS -- Holism.
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HEALTH & FITNESS -- Reference.
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MEDICAL -- Alternative Medicine.
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MEDICAL -- Atlases.
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MEDICAL -- Essays.
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MEDICAL -- Family & General Practice.
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MEDICAL -- Holistic Medicine.
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MEDICAL -- Osteopathy.
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Medical instruments and apparatus
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Surgical instruments and apparatus
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| Added Author |
Tian, Lingling, author.
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Wang, Charlene, author.
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Liao, Susan, author.
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Teo, Wee Eong, author.
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| Other Form: |
Print version: Ramakrishna, Seeram. Medical Devices : Regulations, Standards and Practices. : Elsevier Science, ©2015 9780081002896 |
| ISBN |
9780081002919 (electronic bk.) |
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0081002912 (electronic bk.) |
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9780081002896 |
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0081002890 |
| Standard No. |
AU@ 000055409566 |
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CHBIS 010796039 |
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CHVBK 403951658 |
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DEBSZ 451528573 |
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DEBSZ 482376171 |
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GBVCP 835793133 |
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UKMGB 017438604 |
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