Medical Devices

Medical Devices

Regulations, Standards and Practices

1st Edition - August 18, 2015

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  • Authors: Seeram Ramakrishna, Lingling Tian, Charlene Wang, Susan Liao, Wee Eong Teo
  • Hardcover ISBN: 9780081002896
  • eBook ISBN: 9780081002919

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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.

Key Features

  • Provides readers with a global perspective on medical device regulations
  • Concise and comprehensive information on how to design medical devices to ensure they meet regulations and standards
  • Includes a useful case study demonstrating the design and approval process


regulatory managers, companies that may not employ fulltime regulatory professionals; governmental regulators and manufacturers involved in global biomaterial, biomedical and life science product commercialization; students and graduates in healthcare, business administration and public health

Table of Contents

    • List of contributors
    • Woodhead Publishing Series in Biomaterials
    • 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
      • 2: General regulations of medical devices
        • 2.1 Introduction
        • 2.2 The United States
        • 2.3 The European Union
        • 2.4 China
        • 2.5 Japan
        • 2.6 Australia
        • 2.7 India
        • 2.8 Singapore
        • 2.9 Conclusions
        • FAQs
      • 3: Quality management systems for medical device manufacture
        • 3.1 Introduction
        • 3.2 ISO 13485:2012
        • 3.3 Current good manufacturing practice
        • 3.4 The difference between ISO 13485 and cGMP
        • 3.5 Conclusions
        • FAQs
      • 4: The process of gaining approval for new medical devices
        • 4.1 Introduction
        • 4.2 The United States
        • 4.3 European Union
        • 4.4 China
        • 4.5 Singapore
        • FAQs
    • Part Two: Meeting regulations and standards
      • 5: Risk assessment management for a new medical device
        • 5.1 Introduction
        • 5.2 Risk analysis
        • 5.3 Risk analysis techniques
        • 5.4 Application of risk analysis
        • 5.5 Risk acceptability
        • 5.6 Risk management report
        • FAQs
      • 6: Safety testing of a new medical device
        • 6.1 Introduction
        • 6.2 Absence of toxic substance
        • 6.3 Biocompatibility tests
        • 6.4 Cytotoxicity, sensitization, and irritation
        • 6.5 Systematic/acute, subacute, subchronic, and chronic toxicity
        • 6.6 Genotoxicity, carcinogenicity, and reproductive and development toxicity
        • 6.7 Implantation
        • 6.8 Hemocompatibility
        • 6.9 Biodegradation
        • 6.10 Sterility tests
        • 6.11 Transportation tests
        • 6.12 Electrical appliances tests
        • 6.13 Mechanical tests
        • 6.14 Third-party laboratories testing
        • FAQs
      • 7: Clinical testing of a new medical device
        • 7.1 Introduction: the role of clinical testing
        • 7.2 Setting up and running clinical tests
        • 7.3 Good clinical practices
        • 7.4 Reporting findings
        • 7.5 Future trends
        • FAQs
    • Part Three: Practices
      • 8: Product development overview
        • 8.1 Introduction
        • 8.2 Initiation
        • 8.3 Planning
        • 8.4 Execution, monitoring, and control
        • 8.5 Verification and validation
        • 8.6 Review meetings
        • 8.7 Closure
        • FAQs
      • 9: Case study: successful development and approval of a new medical device
        • 9.1 Introduction
        • 9.2 The approval process
        • 9.3 Lessons learned
        • 9.4 Future trends
        • FAQs
      • 10: Global harmonization of medical devices
        • 10.1 Global Harmonization Task Force and the International Medical Device Regulators Forum
        • 10.2 Working Parties in each continent
        • 10.3 Other societies
        • FAQs
    • References
    • Index

Product details

  • No. of pages: 256
  • Language: English
  • Copyright: © Woodhead Publishing 2015
  • Published: August 18, 2015
  • Imprint: Woodhead Publishing
  • Hardcover ISBN: 9780081002896
  • eBook ISBN: 9780081002919

About the Authors

Seeram Ramakrishna

Seeram Ramakrishna is the Director of the Center for Nanofibres and Nanotechnology at the National University of Singapore (NUS), which is ranked among the top 20 universities in the world. He is regarded as the modern father of electrospinning. He is an elected Fellow of UK Royal Academy of Engineering (FREng); Singapore Academy of Engineering; Indian National Academy of Engineering; and ASEAN Academy of Engineering & Technology. He is an elected Fellow of the International Union of Societies of Biomaterials Science and Engineering (FBSE); Institution of Engineers Singapore; ISTE, India; Institution of Mechanical Engineers and Institute of Materials, Minerals & Mining, UK; and American Association of the Advancement of Science; ASM International; American Society for Mechanical Engineers; American Institute for Medical & Biological Engineering, USA. He is an editor of Elsevier journal Current Opinion in Biomedical Engineering.

Affiliations and Expertise

Director, Center for Nanofibres and Nanotechnology, National University of Singapore (NUS), Singapore

Lingling Tian

Dr. Tian Lingling is a Research Fellow at National University of Singapore, Singapore. She obtained her Ph.D in Textile Engineering from College of Textiles, Donghua University, Shanghai, China in March of 2014. Her research interests include fabrication of electrospun nanofibers and electrosprayed nano/micro-particles, and the application in cardiac, bone and nerve tissue engineering. She has around 10 peer-reviewed journal/conference paper/book chapter publications and one patent.

Affiliations and Expertise

Research Fellow, National University of Singapore, Singapore;

Charlene Wang

Affiliations and Expertise

Laboratory Technologist, National University of Singapore;

Susan Liao

Dr. Susan Liao is Programme manager and Senior Research Fellow at Nanyang Technological University, Singapore. She was Lee Kuan Yew Research Fellow in the Division of Bioengineering and Department of Orthopaedic Surgery, National University of Singapore. She obtained her Ph.D in Biomaterials from the Department of Materials Science and Engineering, Tsinghua University, Beijing, China. Her research interests include Tissue Engineering, Biomimetic nanomaterials, Biomineralization and Cell-biomimetic matrix reactions. She has around 80 peer-reviewed journal/book chapter publications and over 40 international conference presentations. She has also served as an editorial board member for four professional journals and as a reviewer for over forty professional journals.

Affiliations and Expertise

Programme manager and Senior Research Fellow, Nanyang Technological University, Singapore;

Wee Eong Teo

Affiliations and Expertise

Senior Product Engineer, National University of Singapore, Singapore & Biomer Ltd

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