Ramakrishna / Tian / Wang Medical Devices

Regulations, Standards and Practices
1. Auflage 2015
ISBN: 978-0-08-100291-9
Verlag: Morgan Kaufmann
Format: PDF
Kopierschutz: Adobe DRM (»Systemvoraussetzungen)

E-Book, Englisch, 256 Seiten, Format (B × H): 152 mm x 229 mm

Reihe: Woodhead Publishing Series in Biomaterials

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.



- 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

Autoren/Hrsg.

Ramakrishna, Seeram

Tian, Lingling

Wang, Charlene

Liao, Susan

Teo, Wee Eong

Fachgebiete

• Technische Wissenschaften Sonstige Technologien | Angewandte Technik Medizintechnik, Biomedizintechnik
• Rechtswissenschaften Öffentliches Recht Medizin- und Gesundheitsrecht
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizin, Gesundheitswesen Medizintechnik, Biomedizintechnik, Medizinische Werkstoffe
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizin, Gesundheitswesen Medizinrecht, Gesundheitsrecht

Inhaltsverzeichnis

1 Introduction

Part One

2 General regulations of medical devices

3 Quality management systems for medical device manufacture

4 The process of gaining approval for new medical devices

Part Two

5 Risk assessment and management for a new medical device

6 Safety testing of a new medical device

7 Clinical testing of a new medical device

8 Product development overview

Part Three

9 Case study: Successful development and approval of a new medical device

10 Global harmonization of medical devices

Leseproben

Woodhead Publishing Series in Biomaterials
1 Sterilisation of tissues using ionising radiations
Edited by J. F. Kennedy, G. O. Phillips and P. A. Williams 2 Surfaces and interfaces for biomaterials
Edited by P. Vadgama 3 Molecular interfacial phenomena of polymers and biopolymers
Edited by C. Chen 4 Biomaterials, artificial organs and tissue engineering
Edited by L. Hench and J. Jones 5 Medical modelling
R. Bibb 6 Artificial cells, cell engineering and therapy
Edited by S. Prakash 7 Biomedical polymers
Edited by M. Jenkins 8 Tissue engineering using ceramics and polymers
Edited by A. R. Boccaccini and J. Gough 9 Bioceramics and their clinical applications
Edited by T. Kokubo 10 Dental biomaterials
Edited by R. V. Curtis and T. F. Watson 11 Joint replacement technology
Edited by P. A. Revell 12 Natural-based polymers for biomedical applications
Edited by R. L. Reiss et al 13 Degradation rate of bioresorbable materials
Edited by F. J. Buchanan 14 Orthopaedic bone cements
Edited by S. Deb 15 Shape memory alloys for biomedical applications
Edited by T. Yoneyama and S.Miyazaki 16 Cellular response to biomaterials
Edited by L. Di Silvio 17 Biomaterials for treating skin loss
Edited by D. P. Orgill and C. Blanco 18 Biomaterials and tissue engineering in urology
Edited by J. Denstedt and A. Atala 19 Materials science for dentistry
B. W. Darvell 20 Bone repair biomaterials
Edited by J. A. Planell, S. M. Best, D. Lacroix and A. Merolli 21 Biomedical composites
Edited by L. Ambrosio 22 Drug–device combination products
Edited by A. Lewis 23 Biomaterials and regenerative medicine in ophthalmology
Edited by T. V. Chirila 24 Regenerative medicine and biomaterials for the repair of connective tissues
Edited by C. Archer and J. Ralphs 25 Metals for biomedical devices
Edited by M. Ninomi 26 Biointegration of medical implant materials: Science and design
Edited by C. P. Sharma 27 Biomaterials and devices for the circulatory system
Edited by T. Gourlay and R. Black 28 Surface modification of biomaterials: Methods analysis and applications
Edited by R. Williams 29 Biomaterials for artificial organs
Edited by M. Lysaght and T. Webster 30 Injectable biomaterials: Science and applications
Edited by B. Vernon 31 Biomedical hydrogels: Biochemistry, manufacture and medical applications
Edited by S. Rimmer 32 Preprosthetic and maxillofacial surgery: Biomaterials, bone grafting and tissue engineering
Edited by J. Ferri and E. Hunziker 33 Bioactive materials in medicine: Design and applications
Edited by X. Zhao, J. M. Courtney and H. Qian 34 Advanced wound repair therapies
Edited by D. Farrar 35 Electrospinning for tissue regeneration
Edited by L. Bosworth and S. Downes 36 Bioactive glasses: Materials, properties and applications
Edited by H. O. Ylänen 37 Coatings for biomedical applications
Edited by M. Driver 38 Progenitor and stem cell technologies and therapies
Edited by A. Atala 39 Biomaterials for spinal surgery
Edited by L. Ambrosio and E. Tanner 40 Minimized cardiopulmonary bypass techniques and technologies
Edited by T. Gourlay and S. Gunaydin 41 Wear of orthopaedic implants and artificial joints
Edited by S. Affatato 42 Biomaterials in plastic surgery: Breast implants
Edited by W. Peters, H. Brandon, K. L. Jerina, C. Wolf and V. L. Young 43 MEMS for biomedical applications
Edited by S. Bhansali and A. Vasudev 44 Durability and reliability of medical polymers
Edited by M. Jenkins and A. Stamboulis 45 Biosensors for medical applications
Edited by S. Higson 46 Sterilisation of biomaterials and medical devices
Edited by S. Lerouge and A. Simmons 47 The hip resurfacing handbook: A practical guide to the use and management of modern hip resurfacings
Edited by K. De Smet, P. Campbell and C. Van Der Straeten 48 Developments in tissue engineered and regenerative medicine products
J. Basu and J. W. Ludlow 49 Nanomedicine: Technologies and applications
Edited by T. J. Webster 50 Biocompatibility and performance of medical devices
Edited by J-P. Boutrand 51 Medical robotics: Minimally invasive surgery
Edited by P. Gomes 52 Implantable sensor systems for medical applications
Edited by A. Inmann and D. Hodgins 53 Non-metallic biomaterials for tooth repair and replacement
Edited by P. Vallittu 54 Joining and assembly of medical materials and devices
Edited by Y. (Norman) Zhou and M. D. Breyen 55 Diamond-based materials for biomedical applications
Edited by R.Narayan 56 Nanomaterials in tissue engineering: Fabrication and applications
Edited by A. K. Gaharwar, S. Sant, M. J. Hancock and S. A. Hacking 57 Biomimetic biomaterials: Structure and applications
Edited by A. J. Ruys 58 Standardisation in cell and tissue engineering: Methods and protocols
Edited by V. Salih 59 Inhaler devices: Fundamentals, design and drug delivery
Edited by P. Prokopovich 60 Bio-tribocorrosion in biomaterials and medical implants
Edited by Y. Yan 61 Microfluidic devices for biomedical applications
Edited by X-J. James Li and Y....

Über Autor(innen)

Ramakrishna, Seeram
Prof Seeram Ramakrishna is the Director of the Center for Nanofibers & Nanotechnology at the National University of Singapore. He has received awards and recognitions for his pioneering contributions to the field of biomaterials. He specialises in design, processing and validation of biomimetic scaffolds for regeneration of various tissues. He pioneered translucent biomaterials and devices, which are now manufactured and marketed globally by Biomers International. He is an elected international fellow of the Royal Academy of Engineering, UK; Institution of Engineers Singapore; and the American Institute for Medical & Biological Engineering. His research has been translated into products which are available in several countries. He has authored 6 books and more than 500 journal papers.

Liao, Susan
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.

Tian, Lingling
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.