Seeram Ramakrishna,
Lingling Tian,
Charlene Wang,
Susan Liao,
Wee Eong Teo
e.a.
Elsevier Science
e druk, 2015
9780081002896
Medical Devices
Regulations, Standards and Practices
Specificaties
Gebonden, blz.
|
Engels
Elsevier Science |
2015
ISBN13: 9780081002896
Rubricering
Onderdeel van serie
Woodhead Publishing Series in Biomaterials
Levertijd ongeveer 9 werkdagen
Gratis verzonden
Samenvatting
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.
Specificaties
Inhoudsopgave
<p>1 Introduction </p> <p>Part One</p> <p>2 General regulations of medical devices </p> <p>3 Quality management systems for medical device manufacture </p> <p>4 The process of gaining approval for new medical devices </p> <p>Part Two</p> <p>5 Risk assessment and management for a new medical device </p> <p>6 Safety testing of a new medical device</p> <p>7 Clinical testing of a new medical device</p> <p>8 Product development overview </p> <p>Part Three</p> <p>9 Case study: Successful development and approval of a new medical device </p> <p>10 Global harmonization of medical devices </p>