Biomedical Science

Medical Devices

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Biosensors and Environmental Health

Victor R. Preedy, Vinood Patel
August 08, 2012

Discussing the role biosensors play in detecting and monitoring environmental substances, Biosensors and Environmental Health provides key facts that can be applied to other areas of health and disease and a "mini-dictionary" of key terms and summary points. It covers personal toxicity testing,...

Healthcare Sensor Networks: Challenges Toward Practical Implementation

Daniel Tze Huei Lai, Marimuthu Palaniswami, Rezaul Begg
September 28, 2011

Healthcare sensor networks (HSNs) now offer the possibility to continuously monitor human activity and physiological signals in a mobile environment. Such sensor networks may be able to reduce the strain on the present healthcare workforce by providing new autonomous monitoring services ranging...

Handbook of Active Materials for Medical Devices: Advances and Applications

Andres Diaz Lantada
September 28, 2011

This book covers biodevices, mainly implantable or quirurgical, for the diagnosis or treatment of different pathologies, which benefit from the use of active materials as sensors or actuators. Such active or "intelligent" materials are capable of responding in a controlled way to different external...

Safety Evaluation in the Development of Medical Devices and Combination Products, Third Edition

Shayne C. Gad, Shayne C. Gad, Marian G. McCord
October 20, 2008

Capturing the growth of the global medical device market in recent years, this practical new guide is essential for all who are responsible for ensuring safety in the use and manufacture of medical devices. It has been extensively updated to reflect significant advances, incorporating combination...

Pharmaceutical and Medical Device Validation by Experimental Design

Lynn D Torbeck
June 26, 2007

This title demonstrates how designed experiments are the most scientific, efficient, and cost effective method of data collection for validation in a laboratory setting. Intended as a learn-by-example guide, Pharmaceutical and Medical Device Validation by Experimental Design demonstrates why...

Nanoparticle Technology for Drug Delivery

Ram B. Gupta, Uday B. Kompella
January 13, 2006

Nanoparticles, products of nanotechnology, are of increasing interest to the pharmaceutical community. They can increase drug solubility, enhance bioavailability, allow tissue targeting, offer decreased side-effects, and improve therapeutic efficacy. Presenting the most pertinent and practical...

Six Sigma for Medical Device Design

Jose Justiniano, Venky Gopalaswamy
November 15, 2004

For designers of medical devices, the FDA and ISO requirements are extremely stringent. Designers and researchers feel pressure from management to quickly develop new devices, while they are simultaneously hampered by strict guidelines. The Six Sigma philosophy has solved this dichotomous paradigm...

Compact Regs Part 58: CFR 21 Part 58 Good Laboratory Practice for Non-clinical Laboratory Studies 10 Pack, Second Edition

November 17, 2003

This publication contains a verbatim reproduction of 21 CFR Part 58 Good Laboratory Practice for Nonclinical Laboratory Studies....

Practical Design Control Implementation for Medical Devices

Jose Justiniano, Venky Gopalaswamy
March 12, 2003

Bringing together the concepts of design control and reliability engineering, this book is a must for medical device manufacturers. It helps them meet the challenge of designing and developing products that meet or exceed customer expectations and also meet regulatory requirements. Part One covers...

Medical Device Safety: The Regulation of Medical Devices for Public Health and Safety

G.R Higson
October 29, 2001

Medical Device Safety: The Regulation of Medical Devices for Public Health and Safety examines the prospects for achieving global harmonization in medical device regulation and describes a possible future global system. Unresolved difficulties are discussed while solutions are proposed. An...

Handbook of Medical Device Design

Richard C. Fries
September 14, 2000

The Handbook of Medical Device Design  provides a review of regulatory and standards issues in medical device design, including FDA regulations, types of 510 (k), the ISO 9000 series, and medical device directives. It identifies how to determine and document customer needs and device...

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

Herman Pieterse, Peter Duijst, M. G. de Jong
April 30, 1999

The demand for clinical evidence has become an increasingly important issue in the development of medical devices. This demand is reflected not only in regulatory requirements but also by healthcare purchasers as healthcare reforms occur worldwide. Thirteen renowned experts have drawn on their...