Amato / Ezzell Jr Regulatory Affairs for Biomaterials and Medical Devices

1. Auflage 2014
ISBN: 978-0-85709-920-4
Verlag: Elsevier Science & Techn.
Format: EPUB
Kopierschutz: 6 - ePub Watermark

E-Book, Englisch, 202 Seiten

Reihe: Woodhead Publishing Series in Biomaterials

All biomaterials and medical devices are subject to a long list of regulatory practises and policies which must be adhered to in order to receive clearance. This book provides readers with information on the systems in place in the USA and the rest of the world. Chapters focus on a series of procedures and policies including topics such as commercialization, clinical development, general good practise manufacturing and post market surveillance. - Addresses global regulations and regulatory issues surrounding biomaterials and medical devices - Especially useful for smaller companies who may not employ a full time vigilance professional - Focuses on procedures and policies including risk management, intellectual protection, marketing authorisation, university patent licenses and general good practise manufacturing

Autoren/Hrsg.

Amato, Stephen F.

Ezzell Jr, Robert M.

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. Zhou

62 Decontamination in...