Biomedical Science

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

Interpharm
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...

Medical Device Packaging Handbook, Revised and Expanded

Max Sherman
August 25, 1998

This volume details current developments in industry practices and standards relating to medical device packaging. This edition offers entirely new as well as revised chapters on packaging materials, package validation and methods and integrity testing, bar-coding technology, environmentally sound...

Medical Device Quality Assurance and Regulatory Compliance

Richard C. Fries
August 11, 1998

"Acquaints developers of medical devices with the basic concepts and major issues of medical quality assurance and regulatory documents, describes the requirements listed in these documents, and provides strategies for compliance with these requirements."...

Pharmacetical Applications in the European Union: A Guide Through the Registration Maze

Cheng Yee Lowe
February 28, 1998

Written by an expert with twenty years' experience in regulatory affairs in a number of multi-national companies, this book guides readers through the legislative minefield of registering medicinal products in the European Union. Taking a step-by-step approach, the book demystifies all of the...

Metered Dose Inhaler Technology

Tol S. Purewal, David J.W. Grant
December 31, 1997

Metered Dose Inhaler Technology explores the technologies of pressurized metered dose inhalation (MDI) delivery systems and provides practical, easy-to-use guidance to effective product formulation. With contributions from an international panel of authors, the book addresses the global phase-out...

Validation for Medical Device and Diagnostic Manufacturers

Carol V. Desain, Charmaine V. Sutton
September 30, 1997

Implementation of FDA's Design Control requirements (21 CFR 820.30) changed an entire industry. Quality System Requirements defined the approach to medical device validation. Product design, manufacturing process, and test method validation studies must be performed before or as a product is...

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