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Clinical Evaluation and Investigation of Medical Devices under the new EU-Regulation

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The Development of Medical Devices, 30

medicinal products. The recent EU-Regulation on medical devices asks for very requirements regarding the systematic evaluation of medical devices;

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Medical Devices

Medical devices are the bread and butter from which health care and clinical research are derived. Such devices are used for patient care;

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Modern Methods of Clinical Investigation

The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The;

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Managing Medical Devices within a Regulatory Framework

Managing Medical Devices within a Regulatory Framework helps administrators, designers, manufacturers, clinical engineers, and;

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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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Better Regulation in EU Contract Law The Fitness Check and the New Deal for Consumers Studies of the Oxford Institute of European and Comparative Law

This book is the first to provide a critical investigation of EU better regulation from the perspective of EU contract law. The;

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Medical Device Regulations

update the MDD which led to the development and release of the Medical Device Regulation (EU MDR 2017/745). This has since marked the start of a;

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Biomaterials, Medical Devices, and Combination Products

requirements and challenges in evaluating the biocompatibility and clinical safety of the materials used in producing medical devices as well as the;

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Biocompatibility and Performance of Medical Devices

cover key concepts and challenges faced in relation to biocompatibility in medical devices, discuss the evaluation and characterization;

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Economic Evaluation in Clinical Trials

therapy under study. The results of such analysis can affect reimbursement decisions for new medical technologies, drugs, devices or diagnostics;

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CE-Marking

medical devices without being aware of the highly complex registration landscape. Especially in clinical research, the regulations regar;

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International Medical Device Clinical Investigations

The demand for clinical evidence has become an increasingly important issue in the development of medical devices. This demand is reflected;

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Biocompatibility and Performance of Medical Devices

discuss the evaluation and characterisation of biocompatibility in medical devices. Topics covered include material and chemical characterisation;

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Creating 21st Century Medical Devices

regulation of medical devices can affect their cost, quality, and availability in the health care system. This book discusses the legislative history;

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International Medical Device Clinical Investigations: A Practical Approach, Second Edition

The demand for clinical evidence has become an increasingly important issue in the development of medical devices. This demand is reflected;

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New Medical Devices

In the past 50 years the development of a wide range of medical devices has improved the quality of people's lives and revolutionized the;

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A New Model for European Medical Device Regulation

This book analyses the regulation of medical devices at the federal level in the United States and in the European Union. It covers;

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New Technologies and EU Law

What is the nature of the relationship between the fields of new technology and EU law? What challenges do new technologies pose for the;

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Medical Device Technologies

textbook that discusses both electrical and mechanical medical devices. The first 20 chapters are medical device technology chapters; the;

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Medical Product Regulatory Affairs

devoted to national and EU regulatory issues, manufacturing license application and retention, and regulation in the USA. Other topics include;

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Assessing Medical Technologies

Evaluation on the Diffusion of Medical Technology 5. Reimbursement and Technology Assessment 6. Medical Technology Assessment in Developed;

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The Statistical Evaluation of Medical Tests for Classification and Prediction

This book describes statistical techniques for the design and evaluation of research studies on medical diagnostic tests, screening tests;

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Medical Devices & the FDA

Medical device regulation is complex, in part because of the wide variety of items that are categorized as medical devices. They may be;

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Hydrophilic Polymer Coatings for Medical Devices

and devices. It concisely provides both the scientific basics of this class of polymers and the up-to-date information needed for product;

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Hydrophilic Polymer Coatings for Medical Devices

and devices. It concisely provides both the scientific basics of this class of polymers and the up-to-date information needed for product;

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Managed Care and the Evaluation and Adoption of Emerging Medical Technologies

New medical technologies--pharmaceuticals, medical devices, and procedures--often allow great improvements in the outcomes of medical care;

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