Integrated Safety and Risk Assessment for Medical Devices and Combination Products
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TOTAL DOCUMENTS

12

(FIVE YEARS 12)

H-INDEX

0

(FIVE YEARS 0)

Published By Springer International Publishing

9783030352400, 9783030352417

Latest Documents Most Cited Documents Contributed Authors Related Sources Related Keywords

Toxicity of Common Extractables and Leachables of Medical Devices

Integrated Safety and Risk Assessment for Medical Devices and Combination Products ◽

10.1007/978-3-030-35241-7_12 ◽

2019 ◽

pp. 441-461

Author(s):

Kandice M. Nappier ◽

Sherrie Smith

Keyword(s):

Medical Devices

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Introduction: History and Where We Are Headed

Integrated Safety and Risk Assessment for Medical Devices and Combination Products ◽

10.1007/978-3-030-35241-7_1 ◽

2019 ◽

pp. 1-18

Author(s):

Shayne C. Gad

Keyword(s):

Introduction History

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Pathology and Histopathology Evaluations of Biomaterials and Medical Devices

Integrated Safety and Risk Assessment for Medical Devices and Combination Products ◽

10.1007/978-3-030-35241-7_9 ◽

2019 ◽

pp. 339-400

Author(s):

JoAnn C. L. Schuh

Keyword(s):

Medical Devices

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An Introduction to (Q)SAR with Respect to Regulatory Submissions

Integrated Safety and Risk Assessment for Medical Devices and Combination Products ◽

10.1007/978-3-030-35241-7_8 ◽

2019 ◽

pp. 321-337

Author(s):

Jerry L. Bettis

Keyword(s):

Regulatory Submissions

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Bridging Issues of Route

Integrated Safety and Risk Assessment for Medical Devices and Combination Products ◽

10.1007/978-3-030-35241-7_6 ◽

2019 ◽

pp. 273-297

Author(s):

Amy L. Mihalchik-Burhans ◽

Dexter W. Sullivan

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Regulatory Aspects and Strategy in Medical Device and Biomaterials Safety Evaluation

Integrated Safety and Risk Assessment for Medical Devices and Combination Products ◽

10.1007/978-3-030-35241-7_2 ◽

2019 ◽

pp. 19-56

Author(s):

Shayne C. Gad

Keyword(s):

Medical Device ◽

Safety Evaluation ◽

Regulatory Aspects

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Nanodevices

Integrated Safety and Risk Assessment for Medical Devices and Combination Products ◽

10.1007/978-3-030-35241-7_10 ◽

2019 ◽

pp. 401-428

Author(s):

David W. Hobson

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Risk Assessments for Medical Devices

Integrated Safety and Risk Assessment for Medical Devices and Combination Products ◽

10.1007/978-3-030-35241-7_7 ◽

2019 ◽

pp. 299-320

Author(s):

Erica N. Rogers

Keyword(s):

Medical Devices ◽

Risk Assessments

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Considerations for Leachables and Extractables Testing

Integrated Safety and Risk Assessment for Medical Devices and Combination Products ◽

10.1007/978-3-030-35241-7_4 ◽

2019 ◽

pp. 239-263

Author(s):

Amy L. Mihalchik-Burhans ◽

Erica N. Rogers

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Where the Data Is and What Is It?

Integrated Safety and Risk Assessment for Medical Devices and Combination Products ◽

10.1007/978-3-030-35241-7_5 ◽

2019 ◽

pp. 265-271

Author(s):

Sherrie Smith

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