Introduction: Biomaterials in Medical Devices

Frederick J. Schoen; Guigen Zhang

doi:10.1016/B978-0-12-816137-1.00088-X

Introduction: Biomaterials in Medical Devices

Frederick J. Schoen, Guigen Zhang

Research output: Chapter in Book/Report/Conference proceeding › Chapter › peer-review

Abstract

The chapters that comprise Part 3 of this text summarize key principles and provide a “toolkit” for medical device innovation. They discuss total product life cycle for medical devices, safety and risk management, sterilization and disinfection consideration, verification and validation, bench-to-bedside translation, regulatory pathways and constraints, role of standards for testing of biomaterials, implant retrieval, evaluation and analysis, and legal and ethical concerns over the use of biomaterials in medical devices.

Original language	English
Title of host publication	Biomaterials Science
Subtitle of host publication	An Introduction to Materials in Medicine
Pages	1417-1419
Number of pages	3
ISBN (Electronic)	9780128161371
DOIs	https://doi.org/10.1016/B978-0-12-816137-1.00088-X
State	Published - Jan 1 2020

Bibliographical note

Publisher Copyright:
© 2020 Elsevier Inc. All rights reserved.

Keywords

Bench-to-bedside translation
Device failure
Implant retrieval and analysis
Legal concepts
Moral and ethical issues
Product
Regulatory constraints
Safety and risk
Standards
Sterilization and disinfection
Verification and validation

ASJC Scopus subject areas

General Medicine
General Biochemistry, Genetics and Molecular Biology

Access to Document

10.1016/B978-0-12-816137-1.00088-X

Cite this

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KW - Legal concepts

KW - Moral and ethical issues

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KW - Regulatory constraints

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KW - Standards

KW - Sterilization and disinfection

KW - Verification and validation

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Introduction: Biomaterials in Medical Devices

Abstract

Bibliographical note

Keywords

ASJC Scopus subject areas

Access to Document

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