Regulatory Affairs for Biomaterials and Medical Devices
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15

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1

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Published By Elsevier

9780857095428

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Regulatory Affairs for Biomaterials and Medical Devices ◽

10.1016/b978-0-85709-542-8.50015-2 ◽

2015 ◽

pp. 175-185

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The clinical evaluation and approval threshold of biomaterials and medical devices

Regulatory Affairs for Biomaterials and Medical Devices ◽

10.1533/9780857099204.67 ◽

2015 ◽

pp. 67-77 ◽

Author(s):

K.G. Stevens

Keyword(s):

Clinical Evaluation ◽

Medical Devices

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Good manufacturing practice (GMP) for biomaterials and medical devices in the EU and the USA

Regulatory Affairs for Biomaterials and Medical Devices ◽

10.1533/9780857099204.115 ◽

2015 ◽

pp. 115-143 ◽

Author(s):

F. Tarabah

Keyword(s):

Medical Devices ◽

Good Manufacturing Practice ◽

The Usa ◽

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Woodhead Publishing Series in Biomaterials

Regulatory Affairs for Biomaterials and Medical Devices ◽

10.1016/b978-0-85709-542-8.50014-0 ◽

2015 ◽

pp. xi-xv

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Fundamentals of medical device approval in the Asia Pacific region

Regulatory Affairs for Biomaterials and Medical Devices ◽

10.1533/9780857099204.159 ◽

2015 ◽

pp. 159-174

Author(s):

J.L. Wong ◽

P. Teysseyre

Keyword(s):

Medical Device ◽

Asia Pacific ◽

Pacific Region ◽

Asia Pacific Region ◽

Device Approval

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Technical considerations for commercialization of biomaterials

Regulatory Affairs for Biomaterials and Medical Devices ◽

10.1533/9780857099204.11 ◽

2015 ◽

pp. 11-26 ◽

Author(s):

N. Scarborough ◽

N. Mukherjee

Keyword(s):

Technical Considerations

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Clinical development and endpoint strategies for biomaterials and medical devices

Regulatory Affairs for Biomaterials and Medical Devices ◽

10.1533/9780857099204.47 ◽

2015 ◽

pp. 47-66

Author(s):

S.F. Amato

Keyword(s):

Medical Devices ◽

Clinical Development

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Global marketing authorisation of biomaterials and medical devices

Regulatory Affairs for Biomaterials and Medical Devices ◽

10.1533/9780857099204.93 ◽

2015 ◽

pp. 93-114

Author(s):

J.J. Tobin

Keyword(s):

Medical Devices ◽

Marketing Authorisation ◽

Global Marketing

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Postmarket surveillance approaches for biomaterials and medical devices in the USA

Regulatory Affairs for Biomaterials and Medical Devices ◽

10.1533/9780857099204.145 ◽

2015 ◽

pp. 145-157

Author(s):

K. Desai

Keyword(s):

Medical Devices ◽

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Supply chain controls for biomaterials and medical devices in the USA

Regulatory Affairs for Biomaterials and Medical Devices ◽

10.1533/9780857099204.79 ◽

2015 ◽

pp. 79-92

Author(s):

S.F. Amato

Keyword(s):

Supply Chain ◽

Medical Devices ◽

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