Medical Devices
Regulations, Standards and Practices
- 1st Edition - August 18, 2015
- Authors: Seeram Ramakrishna, Lingling Tian, Charlene Wang, Susan Liao, Wee Eong Teo
- Language: English
- Hardback ISBN:9 7 8 - 0 - 0 8 - 1 0 0 2 8 9 - 6
- eBook ISBN:9 7 8 - 0 - 0 8 - 1 0 0 2 9 1 - 9
Medical Devices and Regulations: Standards and Practices will shed light on the importance of regulations and standards among all stakeholders, bioengineering designers, bi… Read more

Purchase options
Institutional subscription on ScienceDirect
Request a sales quoteMedical 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.
- 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
- 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
- 2: General regulations of medical devices
- 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
- 5: Risk assessment management for a new medical device
- 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
- 8: Product development overview
- References
- Index
- No. of pages: 256
- Language: English
- Edition: 1
- Published: August 18, 2015
- Imprint: Woodhead Publishing
- Hardback ISBN: 9780081002896
- eBook ISBN: 9780081002919
SR
Seeram Ramakrishna
LT
Lingling Tian
CW
Charlene Wang
SL
Susan Liao
WT