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First published in 2001: This handbook has been written to give
those professionals working in the development and use of medical
devices practical knowledge about biomedical technology,
regulations, and their relationship to quality health care.
"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."
As medical devices become even more intricate, concerns about
efficacy, safety, and reliability continue to be raised. Users and
patients both want the device to operate as specified, perform in a
safe manner, and continue to perform over a long period of time
without failure. Following in the footsteps of the bestselling
second edition, Reliable Design of Medical Devices, Third Edition
shows you how to improve reliability in the design of advanced
medical devices. Reliability engineering is an integral part of the
product development process and of problem-solving activities
related to manufacturing and field failures. Mirroring the typical
product development process, the book is organized into seven
parts. After an introduction to the basics of reliability
engineering and failures, it takes you through the concept,
feasibility, design, verification and validation, design transfer
and manufacturing, and field activity phases. Topics covered
include Six Sigma for design, human factors, safety and risk
analysis, and new techniques such as accelerated life testing (ALT)
and highly accelerated life testing (HALT). What's New in This
Edition Updates throughout, reflecting changes in the field An
updated software development process Updated hardware test
procedures A new layout that follows the product development
process A list of deliverables needed at the end of each
development phase Incorporating reliability engineering as a
fundamental design philosophy, this book shares valuable insight
from the author's more than 35 years of experience. A practical
guide, it helps you develop a more effective reliability
engineering program-contributing to increased profitability, more
satisfied customers, and less risk of liability.
As medical devices become even more intricate, concerns about
efficacy, safety, and reliability continue to be raised. Users and
patients both want the device to operate as specified, perform in a
safe manner, and continue to perform over a long period of time
without failure. Following in the footsteps of the bestselling
second edition, Reliable Design of Medical Devices, Third Edition
shows you how to improve reliability in the design of advanced
medical devices. Reliability engineering is an integral part of the
product development process and of problem-solving activities
related to manufacturing and field failures. Mirroring the typical
product development process, the book is organized into seven
parts. After an introduction to the basics of reliability
engineering and failures, it takes you through the concept,
feasibility, design, verification and validation, design transfer
and manufacturing, and field activity phases. Topics covered
include Six Sigma for design, human factors, safety and risk
analysis, and new techniques such as accelerated life testing (ALT)
and highly accelerated life testing (HALT). What's New in This
Edition Updates throughout, reflecting changes in the field An
updated software development process Updated hardware test
procedures A new layout that follows the product development
process A list of deliverables needed at the end of each
development phase Incorporating reliability engineering as a
fundamental design philosophy, this book shares valuable insight
from the author's more than 35 years of experience. A practical
guide, it helps you develop a more effective reliability
engineering program-contributing to increased profitability, more
satisfied customers, and less risk of liability.
First published in 2001: This handbook has been written to give
those professionals working in the development and use of medical
devices practical knowledge about biomedical technology,
regulations, and their relationship to quality health care.
This essential reference 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. Medical Device Quality Assurance and
Regulatory Compliance summarizes regulation activities of the FDA,
the European Economic Community, and the Global Harmonization Task
Force shows how to choose a standard from the ISO 9000 and ISO
14000 series teaches how to prepare your company for auditing, how
to choose a notified body, and how to survive the audit reviews
standards dealing specifically with medical devices such as EN
46000, ISO 13485, and ISO 13488 discusses the requirements for
product submittals prior to product introduction addresses current
issues such as third party approvals and more Including numerous
key references, tables, and drawings, Medical Device Quality
Assurance and Regulatory Compliance is ideal for biomedical,
quality assurance, reliability, software, product design,
manufacturing, research and development, and industrial engineers;
project managers; biomedical technicians; medical device purchasing
personnel; and upper-level undergraduate and graduate students in
these disciplines.
This fourth edition is a substantial revision of a highly regarded
text, intended for senior design capstone courses within
departments of biomedical engineering, bioengineering, biological
engineering and medical engineering, worldwide. Each chapter has
been thoroughly updated and revised to reflect the latest
developments. New material has been added on entrepreneurship,
bioengineering design, clinical trials and CRISPR. Based upon
feedback from prior users and reviews, additional and new examples
and applications, such as 3D printing have been added to the text.
Additional clinical applications were added to enhance the overall
relevance of the material presented. Relevant FDA regulations and
how they impact the designer's work have been updated. Features
Provides updated material as needed to each chapter Incorporates
new examples and applications within each chapter Discusses new
material related to entrepreneurship, clinical trials and CRISPR
Relates critical new information pertaining to FDA regulations.
Presents new material on "discovery" of projects "worth pursuing"
and design for health care for low-resource environments Presents
multiple case examples of entrepreneurship in this field Addresses
multiple safety and ethical concerns for the design of medical
devices and processes
Frederic, who is shy and sensitive, and Hugo, who is heartless and
aggressive. Frederic is in love with a hussy who is in love with
Hugo. To save Frederic from an unhappy marriage, Hugo tries to
distract him by bringing to a ball a beautiful dancer who
masquerades as a mysterious personage and becomes the triumph of
the occasion. She is a susceptible maiden in her own right. She not
only breaks up all the cynical romances that have been going on
before she arrived, but loses her own heart as well.6 women, 8 men
A balanced introduction to the theoretical foundations and
real-world applications of mathematical finance
The ever-growing use of derivative products makes it essential
for financial industry practitioners to have a solid understanding
of derivative pricing. To cope with the growing complexity,
narrowing margins, and shortening life-cycle of the individual
derivative product, an efficient, yet modular, implementation of
the pricing algorithms is necessary. "Mathematical Finance" is the
first book to harmonize the theory, modeling, and implementation of
today's most prevalent pricing models under one convenient cover.
Building a bridge from academia to practice, this self-contained
text applies theoretical concepts to real-world examples and
introduces state-of-the-art, object-oriented programming techniques
that equip the reader with the conceptual and illustrative tools
needed to understand and develop successful derivative pricing
models.
Utilizing almost twenty years of academic and industry
experience, the author discusses the mathematical concepts that are
the foundation of commonly used derivative pricing models, and
insightful Motivation and Interpretation sections for each concept
are presented to further illustrate the relationship between theory
and practice. In-depth coverage of the common characteristics found
amongst successful pricing models are provided in addition to key
techniques and tips for the construction of these models. The
opportunity to interactively explore the book's principal ideas and
methodologies is made possible via a related Web site that features
interactive Java experiments and exercises.
While a high standard of mathematical precision isretained,
"Mathematical Finance" emphasizes practical motivations,
interpretations, and results and is an excellent textbook for
students in mathematical finance, computational finance, and
derivative pricing courses at the upper undergraduate or beginning
graduate level. It also serves as a valuable reference for
professionals in the banking, insurance, and asset management
industries.
Compiling an abundant catalog of the essential criteria and methods
for the design of medical devices, this comprehensive reference
supplies insights into a rapidly evolving field-spanning practical
knowledge, field tracking, valuable timesaving techniques, and the
latest innovations. Reviews current regulatory and standards
issues, including FDA regulations, types of 510 (k), the ISO 9000
series, and medical device directives Foreseeing a variety of
concerns and obstacles, the Handbook of Medical Device Design
identifies how to determine and document customer needs and device
requirements establishes reliability and quality metrics for the
duration of the product development cycle compares international
regulations and standards, in Europe, Canada, Japan, and Australia
illustrates electrical, mechanical, hardware, software, and
industrial design considerations discusses biocompatibility,
safety/risk analysis, third-party certification, technical
documentation, translations, and life-cycle costs of implantable
equipment thoroughly examines manufacturing processes such as
quality system regulation and preparation for the quality system
audit and more Includes useful appendices of tables and a glossary
Written by experienced practitioners and authorities in the field,
the Handbook of Medical Device Design is a necessary and worthwhile
reference and guidebook for biomedical, quality assurance,
reliability, software, product design, manufacturing, research and
development, and industrial engineers; project managers; biomedical
technicians, medical device purchasing personnel; and upper-level
undergraduate and graduate students in these disciplines.
Science and Practice of Strength Training is a favorite book among
strength and conditioning professionals. Now in a third edition, it
offers upgraded artwork, updates based on current science, and new
information to enhance the practical application of the concepts
presented. A new coauthor, Dr. Andrew Fry, joins the
already-popular author team of Dr. Vladimir Zatsiorsky and Dr.
William Kraemer to make this third edition even better than its
predecessors. Together the authors have trained more than 1,000
elite athletes, including Olympic medal winners, world champions,
and national record holders. Influenced by both Eastern European
and North American perspectives, their experience and expertise are
integrated into solid principles, practical insights, and
directions based on scientific findings. Science and Practice of
Strength Training, Third Edition, shows that there is no single
program that works for everyone, at all times and in all
conditions. It addresses the complexity of strength training
programs while providing straightforward approaches to take under
specific circumstances. Those approaches are backed with
physiological concepts, ensuring readers gain a full understanding
of the science behind the practice of strength training. In
addition, the authors provide examples of strength training
programs to demonstrate the principles and concepts they explain in
the book. The third edition features more detailed artwork and has
three new chapters on velocity in the weight room, overtraining and
recovery, and athlete monitoring. The book is divided into three
parts. Part I focuses on the basis of strength training, detailing
basic concepts, task-specific strength, and athlete-specific
strength. Part II covers methods of strength training, delving into
velocity training, training intensity, timing, exercises used for
strength training, injury prevention, overtraining, athlete
monitoring, and goal-specific strength training. Part III offers
even more practical applications, exploring training for specific
populations, including women, young athletes, and senior athletes.
The book also includes suggested readings that can further aid
readers in developing strength training programs. This expanded and
updated coverage of strength training concepts will ground readers
in the understanding they need to develop appropriate strength
training programs for each person that they work with. Earn
continuing education credits/units! A continuing education exam
that uses this book is also available. It may be purchased
separately or as part of a package that includes both the book and
exam.
Sherlock Holmes and John Watson have wandered far from the light of
Victorian gas lamps. As Holmes and Watson they've tangled with
Nazis, as Sherlock and John they roam the corridors of New Scotland
Yard. In a world of so many fresh adventures, why not fresh
beginnings to those adventures? From an 1879 Kabul train station to
a King's College lecture theatre in 2015, The Day They Met includes
stories both classic and contemporary, offering fifty intriguing
new ways that the world's most legendary partnership might have
begun.
A internationally renowned academic and a local practitioner
combine insights and experiences to aid local government leaders in
assessing public service alternatives. Their framework is
straightforward and goes well beyond the simplistic assumptions of
economies of scale. This book could not be more timely.
Additional Contributors Include Joseph Wood Krutch, Anna F. Haig,
Warren Creel, Emma Johnston, W. H. Wilcox And Others.
First published in 1988 and now known as a classic. In this book
Stephen Fry describes, in bench-top detail, techniques for the
study of primary cell walls in higher plants. Deepening interest in
the chelistry and metabolism of cell walls reflects the breadth of
their significance in biology. Walls play crutial roles in
morphogenesis, growth, disease-resistance, recognition, signalling,
digestibility, nutrition and decay. Scientists interested in
questions concerning these processes need to know about methods of
cell wall analysis. This book was written with these people in
mind. There are 11 chapters as follows: 1. Introduction to the
growing plant cell wall 2. Radioactive labelling of cell walls 3.
Wall polymers: extraction and fractionation 4. Wall polymers:
chemical characterisation 5. Wall biosyntesis 6. Wall enzymes 7.
Wall architecture 8. Wall turnover and sloughing 9.
Biologically-active wall oligosaccharides 10. Wall tightening and
loosening: growth 11. Wall degradation "Stephen Fry has written an
invaluable book on the analytical techniques available in this
important research field. This is an excellent book for the typical
modern biologist." J. Experimental Biology "This book will be of
considerable value to anyone engaged in the analysis of plant cell
walls." Ann. Botany "For those who intend to do any practical cell
wall analysis this book will be an invaluable laboratory manual."
Plant Pathology "As a practical guide to wall analysis this book
will be a most valuable tool." Times Higher Education Supplement
Cada nudo ha sido ilustrado paso a paso, incluyendo fotografias de
las manos manipulando el cabo, lo que facilitara al lector el
seguimiento de las secuencias.
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