Liao S., Ramakrishna S., Teo Wee E., Tian L., Wang C. Medical devices: regulations, standards and practices

Amsterdam: Woodhead Publishing, 2015. — 253 p.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.Medical Devices: Regulations, Standards and Practices
CopyrightList of contributors
Woodhead Publishing Series in Biomaterials
Chapter : Introduction
Medical devices: definitions and types
Market trend
Safety issues
The development of regulations and standards
The structure of this book
FAQs
Part One: Regulations and standards
Chapter : General regulations of medical devicesThe United States
The regulatory authority for medical devices and its organization in the United States
Classification of medical devices and the relevant controls in the United States
Practical guide to identifying the medical devices classification in the United States
The European Union
Regulatory framework for medical devices in the EU
New changes in EU regulation
Differences between the regulations for medical devices in the United States and the EU
China
The regulatory framework for medical devices in China Changes in Chinese regulations
The evolution of CFDA
Revised regulation on the supervision and administration of medical devices
Japan
Australia
India
Singapore
Regulatory framework for medical devices in Singapore
Grouping of medical devices for production registration in Singapore
Conclusions
FAQs
Chapter : Quality management systems for medical device manufactureHistory of QSR 21 CFR 820
History of ISO 13485
ISO 13485:2012
General requirements of ISO 13485:2012
Document control required by ISO 13485:2012
Quality manual
Control of documents
Control of records
Processes required by ISO 13485
Implementation
Process effectiveness
Conformity assessment, registration, and certification processes
Conformity assessment
Certification
ISO 13485 application in various countries
EU
Canada
Japan
Current good manufacturing practice
The difference between ISO 13485 and cGMP
Conclusions
FAQs
Chapter : The process of gaining approval for new medical devicesThe United States
Step : Classify device
Step : Choose correct premarket submission
Step : Prepare documents for submission to the FDA
Class I process
Class II process-510(k)