Sign-In
Cart
Safety Risk Management for Medical Devices
Paperback
Medical ReferenceTechnology & Engineering
Currently unavailable to order
Please enter your email and a message will be sent to you when this product becomes available on our website.
ISBN13: 9780128130988
Publisher: Academic Pr Inc
Published: Jul 3 2018
Pages: 424
Weight: 1.60
Height: 0.87 Width: 7.50 Depth: 9.25
Language: English
Safety Risk Management for Medical Devices demystifies risk management, providing clarity of thought and confidence to the practitioners of risk management as they do their work. Written with practicing engineers, safety management professionals, and students in mind, this book will help readers tackle the difficult questions, such as how to define risk acceptance criteria and how to determine when to stop risk reduction.
This book delivers not only theory, but also practical guidance for applying the theory in daily risk management work. The reader is familiarized with the vocabulary of risk management and guided through a process to ensure compliance with the international standard ISO 14971--a requirement for all medical devices. This book outlines sensible, easily comprehensible, and state-of the-art methodologies that are rooted in current industry best practices.
Opening chapters introduce the concept of risk, the legal basis for risk management, and the requirements for a compliant risk-management process. The next group of chapters discusses the connection between risk management and quality systems, usability engineering and biocompatibility. This book delves into the techniques of risk management, such as fault tree analysis and failure modes and effects analysis, and continues with risk estimation, risk control, and risk evaluation. Special topics such as software risk management, clinical investigations, and security are also discussed. The latter chapters address benefit-risk analysis, and production and postproduction monitoring. This book concludes with advice and wisdom for sensible, efficient, and successful safety risk management of medical devices.
Also in
Technology & Engineering
All Data Are Local: Thinking Critically in a Data-Driven Society
Loukissas, Yanni Alexander
Paperback
The Age of Living Machines: How Biology Will Build the Next Technology Revolution
Hockfield, Susan
Paperback
Ingenious Patents: Bubble Wrap, Barbed Wire, Bionic Eyes, and Other Pioneering Inventions
Ikenson, Ben
Bennett, Jay
Hardcover
The Reverse Centaur's Guide to Life After AI: How to Think about Artificial Intelligence--Before It's Too Late
Doctorow, Cory
Paperback
Improvised Munitions Black Book: Complete and Unabridged in One Volume: Complete and Unabridged in One Volume
U S Government
Paperback
The Infinity Machine: Demis Hassabis, Deepmind, and the Quest for Superintelligence
Mallaby, Sebastian
Hardcover
AI for Good: How Real People Are Using Artificial Intelligence to Fix Things That Matter
Tyrangiel, Josh
Hardcover
The Story of Your Life: How Social Media Shapes the Way We Experience Everything
Jezer-Morton, Kathryn
Hardcover
Ultimate Guide: Wiring, Updated 10th Edition: Meets Current National Electrical Code Standards
The Editors of Creative Homeowner
Paperback
Like, Follow, Subscribe: Influencer Kids and the Cost of a Childhood Online
Latifi, Fortesa
Hardcover
Lightning Beneath the Sea: The Race to Wire the World and the Dawn of the Information Age
Tabor, James M.
Hardcover
Basic Butchering of Livestock & Game: Beef, Veal, Pork, Lamb, Poultry, Rabbit, Venison
Mettler, John J.
Paperback
No One's Coming: The Rogue Heroes Our Government Turns to When There's Nowhere Else to Turn
Hazzard, Kevin
Hardcover
The Agi Chronicles: The Inside Story of the Race to Create an Artificial Superintelligence
Roose, Kevin
Hardcover
Empire of Ink: The Printers, Rogues, and Radicals Who Invented the American Newspaper
Wright, Alex
Hardcover
The Problem with Plastic: How We Can Save Ourselves and Our Planet Before It's Too Late
Beyond Plastics
Enck, Judith
Mahoney, Adam
Hardcover
The Elements of Power: A Story of War, Technology, and the Dirtiest Supply Chain on Earth
Niarchos, Nicolas
Hardcover
Midnight in Chernobyl: The Untold Story of the World's Greatest Nuclear Disaster
Higginbotham, Adam
Paperback
The Home Blacksmith: Tools, Techniques, and 40 Practical Projects for the Home Blacksmith
Ridgway, Ryan
Paperback
Atlas of AI: Power, Politics, and the Planetary Costs of Artificial Intelligence
Crawford, Kate
Paperback
City on the Edge: Technology, Politics, and the Fight for the Soul of San Francisco
Weber, Jonathan
Hardcover
You Don't Need a Smartphone: A Practical Guide to Downgrading Your Phone and Upgrading Your Life
Lamm, August
Paperback
AI Snake Oil: What Artificial Intelligence Can Do, What It Can't, and How to Tell the Difference
Narayanan, Arvind
Kapoor, Sayash
Paperback
Generation Regeneration: Codesigning the Future of Cities Through Regenerative Placemaking
Cho, Tony
Hardcover
The Baofeng Radio Revolution: The Beginner Guerrilla's Guide to Break Through the Complexity, Secure Communications, and Prepare for Disaster With Pre
Code Publishing, Morse
Hardcover
The New Age of Sexism: How AI and Emerging Technologies Are Reinventing Misogyny
Bates, Laura
Hardcover
Meat: How the Next Agricultural Revolution Will Transform Humanity's Favorite Food--And Our Future
Friedrich, Bruce
Hardcover
Inconspicuous Consumption: The Environmental Impact You Don't Know You Have
Schlossberg, Tatiana
Paperback
Crisis Engineering: Time-Tested Tools for Turning Chaos Into Clarity
Nitze, Marina
Weaver, Matthew
Dickerson, Mikey
Paperback
The Trillion Dollar War Machine: How Runaway Military Spending Drives America Into Foreign Wars and Bankrupts Us at Home
Hartung, William D.
Freeman, Ben
Hardcover
Human + Machine, Updated and Expanded: Reimagining Work in the Age of AI
Daugherty, Paul R.
Wilson, H. James
Hardcover
Artificial Intelligence: A Guide for Thinking Humans (with a New Preface)
Mitchell, Melanie
Paperback
Curved Air: A Biography of Sickle Cell Anemia and the Quest to Cure the First Molecular Disease
Davies, Kevin
Hardcover
The Boy Who Harnessed the Wind: Creating Currents of Electricity and Hope
Mealer, Bryan
Kamkwamba, William
Paperback
Tubes: A Journey to the Center of the Internet with a New Introduction by the Author
Blum, Andrew
Paperback
Bringing Columbia Home: The Untold Story of a Lost Space Shuttle and Her Crew
Leinbach, Michael D.
Ward, Jonathan H.
Paperback
Broken Money: Why Our Financial System is Failing Us and How We Can Make it Better
Alden, Lyn
Paperback
CompTIA Tech+ Certification All-in-One Exam Guide, Third Edition (Exam FC0-U71)
Wempen, Faithe
Paperback
CNC Woodworking for the Absolute Beginner: Winning Tips, Techniques & 5 Skill-Building Projects
Bagnall, Ralph
Paperback
Pilot's Handbook of Aeronautical Knowledge: Faa-H-8083-25c
Federal Aviation Administration (FAA)
Hardcover
The Ultimate Guide to Rebuilding a Civilization: A Technical Manual for the Post-Collapse Era
Evans, James
Paperback
AI Projects with Raspberry Pi: High-Performance Artificial Intelligence for Robotics, Security, Home Automation, and Vision
Hattersley, Lucy
Jepson, Brian
Paperback
Disneyland and the Rise of Automation: How Technology Created the Happiest Place on Earth
Betancourt, Roland
Hardcover
Make: Electronics: Learning by Discovery: A Hands-On Primer for the New Electronics Enthusiast
Platt, Charles
Paperback
Cadillac Desert: The American West and Its Disappearing Water, Revised Edition
Reisner, Marc
Paperback
The Powerful Primate: How Controlling Energy Enabled Us to Build Civilization
Ennos, Roland
Hardcover
AI Snake Oil: What Artificial Intelligence Can Do, What It Can't, and How to Tell the Difference
Narayanan, Arvind
Kapoor, Sayash
Hardcover
Agentic Artificial Intelligence: Harnessing AI Agents to Reinvent Business, Work, and Life
Bornet
Wirtz, Jochen
Davenport, Thomas H.
Paperback
Drawing Lessons with Da Vinci: An Artist's Guide to Geometry, Anatomy and Proportion
Roig, Gabriel Martín
Paperback
The Fourth Intelligence Revolution: The Future of Espionage and the Battle to Save America
Vinci, Anthony
Hardcover
Texas DMV Driver's Handbook: Practice for the Texas Permit Test with 350+ Driving Questions and Answers
Prep, Discover
Paperback
The Mercury 13: The True Story of Thirteen Women and the Dream of Space Flight
Ackmann, Martha
Paperback
Agentic Artificial Intelligence: Harnessing AI Agents to Reinvent Business, Work, and Life
Davenport, Thomas H.
Bornet, Pascal
Wirtz, Jochen
Hardcover
The Unaccountability Machine: Why Big Systems Make Terrible Decisions--And How the World Lost Its Mind
Davies, Dan
Paperback
Bioinspired: How Nature Made Us Modern, Drives Today's Technological Innovation, and Inspires a Future Worth Inventing
Stier, Samuel Cord
Hardcover
Inconspicuous Consumption: The Environmental Impact You Don't Know You Have
Schlossberg, Tatiana
Hardcover
Feed the People!: Why Industrial Food Is Good and How to Make It Even Better
Dutkiewicz, Jan
Rosenberg, Gabriel N.
Hardcover
The Coming Wave: Technology, Power, and the Twenty-First Century's Greatest Dilemma
Suleyman, Mustafa
Hardcover
Kobuk the Destroyer: And Other Tales from the Wild, Unseen World of Test Engineering
Davies, Alex
Hardcover
Trapped Under the Sea: One Engineering Marvel, Five Men, and a Disaster Ten Miles Into the Darkness
Swidey, Neil
Paperback
The Ultimate Guide to Skinning and Tanning: A Complete Guide to Working with Pelts, Fur, and Leather
Burch, Monte
Paperback
Longitude: The True Story of a Lone Genius Who Solved the Greatest Scientific Problem of His Time
Sobel, Dava
Paperback
What Is Intelligence?: Lessons from AI about Evolution, Computing, and Minds
Aguera Y. Arcas, Blaise
Paperback
Engineering in Plain Sight: An Illustrated Field Guide to the Constructed Environment
Hillhouse, Grady
Hardcover