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Biomaterials, Medical Devices, and Combination Products

Biomaterials, Medical Devices, and Combination Products is a single-volume guide for those responsible for-or concerned with-developing and;

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Safety Risk Management for Medical Devices

Safety Risk Management for Medical Devices, Second Edition teaches the essential safety risk management methodologies for medical;

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Integrated Safety and Risk Assessment for Medical Devices and Combination Products

While the safety assessment (“biocompatibility”) of medical devices has been focused on issues of local tissue tolerance (irritation;

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Safety Evaluation in the Development of Medical Devices and Combination Products

for ensuring safety in the use and manufacture of medical devices. It has been extensively updated to reflect significant advances;

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Nanotoxicity

of nanomaterials in foods, drugs, medical devices, cosmetics and other regulated products and its use in risk analysis for potential regulatory use;

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The Design and Manufacture of Medical Devices

its proper application, intended by the manufacturer to be used for human beings. The design and manufacture of medical devices brings;

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Safety Risk Management for Medical Devices

Safety Risk Management for Medical Devices demystifies risk management, providing clarity of thought and confidence to the;

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Assurance of Sterility for Sensitive Combination Products and Materials

Assurance of Sterility for Sensitive Combination Products and Materials: New Paradigms for the Next Generation of Medical Devices and;

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A Simple Guide to Understanding Medical Device Regulations

the safety of medical devices and who is responsible for implementation, applying conformity assessment rules and the use of standards to;

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ISO 13485 - the Quality Management System for Medical Devices

two then examines the key area of Design controls and there application to medical devices. Finally, a review of Quality Risk management;

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Creating 21st Century Medical Devices

responsible for protecting the public health by assuring the safety, efficacy, and security of human medical devices and other products. The;

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Sources of Contamination in Medicinal Products and Medical Devices

that undermine the safety of medicines and medical devices.;

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Trends in Development of Medical Devices

effects, risk assessment and mitigation. It also discusses the maintenance of a medical device portfolio during product lifecycle. This book;

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CE-Marking

/385/EEC for active implantable medical device, 93/42/EEC for medical devices and 98/79/EEC for in vitro diagnostic devices. With the;

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Biocompatibility and Performance of Medical Devices

, allowable limits for toxic leachables, in vivo and in vitro testing and blood compatibility assessment. Testing and interpreting medical device;

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Safe Medical Devices for Children

Innovative medical devices have helped reduce the burden of illness and injury and improve the quality of life for countless children;

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Medical Product Safety Evaluation

methods that are tailored to specific objectives and data types for safety analysis and benefit-risk assessment. Some frequently encountered;

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Medical Product Safety Evaluation

methods that are tailored to specific objectives and data types for safety analysis and benefit-risk assessment. Some frequently encountered;

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Integrated Life-Cycle and Risk Assessment for Industrial Processes and Products

Featuring contributions from leading experts, Integrated Life-Cycle and Risk Assessment for Industrial Processes and Products is a great reference;

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Integrated Life-Cycle and Risk Assessment for Industrial Processes and Products

engineered nanomaterials Featuring contributions from leading experts, Integrated Life-Cycle and Risk Assessment for Industrial;

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System Safety Engineering and Risk Assessment

. Employing highly pragmatic examples from a number of industries, System Safety Engineering and Risk Assessment: A Practical Approach provides a;

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Regulatory Toxicology, Third Edition

chapters written by experts with extensive experience in the field address requirements not only for human pharmaceuticals and medical devices (for;

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Guidelines for Failure Modes and Effects Analysis for Medical Devices

consistency while dramatically cutting the time required for studies, Guidelines for Failure Modes and Effects Analysis for Medical Devices focuses on;

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Guidelines for Failure Modes and Effects Analysis for Medical Devices

consistency while dramatically cutting the time required for studies, Guidelines for Failure Modes and Effects Analysis for Medical Devices focuses on;

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Advances in Safety and Reliability - ESREL 2005, Two Volume Set

well as methods for the assessment and management of risks. Set in a wide range of industrial, societal and governmental sectors, the book;

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Dose, Benefit, and Risk in Medical Imaging

This timely overview of dose, benefit, and risk in medical imaging explains to readers how to apply this information for informed decision;

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Dose, Benefit, and Risk in Medical Imaging

This timely overview of dose, benefit, and risk in medical imaging explains to readers how to apply this information for informed decision;

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