Biomedical Science

Medical Devices

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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....

Compact Regs Parts 807, 812, and 814: CFR 21 Parts 807, 812, and 814 Medical Device Approval (10 Pack)

November 17, 2003

Supplemented with a convenient keyword index, this book provides a pocket-sized verbatim reproduction of key US FDA regulations. It presents the requirements as set forth by the FDA CFR 21 Parts 807, 812, and 814 to sell or distribute medical devices, including the pre-market approval requirements...

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...

Medical Device Reliability and Associated Areas

B.S. Dhillon
March 29, 2000

Although Reliability Engineering can trace its roots back to World War II, its application to medical devices is relatively recent, and its treatment in the published literature has been quite limited. With the medical device industry among the fastest growing segments of the US economy, it is...

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...

Sterilization of Medical Devices

Anne Booth
November 30, 1998

This book presents vital information on international sterilization standards and guidance on practical application of these standards in the manufacturing process. It covers validation, industrial sterilization methods, emerging sterilization techniques, laboratory testing, manufacturing of...