This design methodology enables engineers and medical device manufacturers to bring new products to the marketplace rapidly. The medical device market is a multi-billion dollar industry. Engineers failing to meet these requirements can cause serious harm to users as well as their products’ commercial prospects.
This book shows howcovers us, enabling a truly international approach, and EU and ISO standards, providing a guide to the international standards that practicing engineers require to understandWritten by an experienced medical device engineers and entrepreneurs with products in the from the US and UK and with real world experience of developing and commercializing medical products .
Medical Device Design: Innovation from Concept to Market #ad - It addresses medical devices' regulatory FDA and EU requirements--some of the most stringent engineering requirements globally. It brings together proven design protocols and puts them in an explicit medical context based on the author's years of academia R&D phase and industrial commercialization phase experience.
Every engineered product for this sector, from scalpelsstents to complex medical equipment, must be designed and developed to approved procedures and standards.
Biodesign: The Process of Innovating Medical TechnologiesCambridge University Press #ad - This step-by-step guide to medical technology innovation, now in full color, has been rewritten to reflect recent trends of industry globalization and value-conscious healthcare. Cambridge University Press. Written by a team of medical, invention, engineering, researchers, the authors provide a comprehensive resource that leads students, and business experts, and entrepreneurs through a proven process for the identification, and implementation of new solutions.
A wealth of additional material supports the book, supplementary appendices, including a collection of nearly 100 videos created for the second edition, active links to external websites, and timely updates on the companion website at ebiodesign. Org. Case studies on innovative products from around the world, successes and failures, practical advice, and end-of-chapter 'Getting Started' sections encourage readers to learn from real projects and apply important lessons to their own work.
Biodesign: The Process of Innovating Medical Technologies #ad - Readers can access this material quickly, easily, and at the most relevant point in the text from within the ebook.
The Medical Device R&D HandbookCRC Press #ad - Used book in Good Condition. The text also contains interviews with leaders in the industry who offer their vast experience and insights on how to start and grow successful companies―both what works and what doesn’t work. Cambridge University Press. This updated and expanded edition adds new information to help meet the challenges of the medical device industry, operating room observation protocol, including strategic intellectual property management, and the use of new technologies and new materials in device development.
Exploring the practical, entrepreneurial, and historical aspects of medical device development, this second edition of The Medical Device R&D Handbook provides a how-to guide for medical device product development. The book offers knowledge of practical skills such as prototyping, plastics selection, and catheter construction, allowing designers to apply these specialized techniques for greater innovation and time saving.
The Medical Device R&D Handbook #ad - The author discusses the historical background of various technologies, helping readers understand how and why certain devices were developed.
The Medical Device Engineers HandbookCreateSpace Independent Publishing Platform #ad - The objective was to produce an all-in-one reference-style book serving the needs of engineers at different levels in their career journey. It draws not only on this experience but on best practices and widely accepted conventions. These practices and conventions are typically shaped by the demands of regulatory bodies and international organisations.
Chapters include:design controls validation planningrisk managementfacilities and utilities validationEquipment and Software ValidationProcess ValidationPackaging ValidationTest Method Validation21 CFR Part 11 Electronic RecordsMeasurementGood Manufacturing PracticesISO 13485 Lean BasicsSix Sigma Basics Polymer ProcessingToolsUseful References Page Count Over 200 pages Cambridge University Press.
The Medical Device Engineers Handbook #ad - It is based on over a decade of experience working within the industry. This book aims to create a new standard resource for engineers working in the medical device industry. Used book in Good Condition.
Contextual Inquiry for Medical Device DesignAcademic Press #ad - The text explains the concept of contextual inquiry using real-life examples to illustrate its application. Contextual inquiry for medical device Design helps users understand the everyday use of medical devices and the way their usage supports the development of better products and increased market acceptance.
Used book in Good Condition. Case studies provide a frame of reference on how contextual inquiry is successfully used during product design, ultimately producing safer, improved medical devices. Presents the ways contextual inquiry can be used to inform the evaluation and business case of technologyHelps users understand the everyday use of medical devices and the way their usage supports the development of better products Includes case studies that provide a frame of reference on how contextual inquiry is successfully used during the product design process Cambridge University Press.
Product Launch: Practical Guide to Launching Medical Device ProductsKerr Consulting Group LLC #ad - Cambridge University Press. Used book in Good Condition. This book, helps marketing professionals master the eight simple, by seasoned veterans of many successful product launches, proven steps that will guarantee a world-class product launch. A new device must be better for the patient and the physician-and its proven clinical benefits must translate into financial savings for the hospital and the healthcare system.
If a new medical device is to succeed, it must deliver both superior clinical outcomes and economic advantage.
Design Controls, Risk Management & Process Validation for Medical Device Professionals: A Comprehensive Handbook for Interpreting and Implementing Design Control RegulationDesign Controls, Risk Management and Process Validation for Medical Device Professionals #ad - This handbook is ranked as a best seller and provides the most up to date resource currently available for interpreting and understanding design controls. This handbook is the most exhaustive resource ever written about FDA design controls for medical devices with a collection of all applicable regulations and real-world examples.
In addition, risk management, compliance to design controls, bonus chapters include: explanation of medical device classification, and the design control quality system preamble. Cambridge University Press. Interpretation of design Control Regulation 21 CFR 8203030-50 pages are dedicated to each of the major design control topics: Design and Development Planning, Design Verification, Design Validation, Design Output, Design Transfer, Design Input, Design Change and Design History File.
Design Controls, Risk Management & Process Validation for Medical Device Professionals: A Comprehensive Handbook for Interpreting and Implementing Design Control Regulation #ad - Used book in Good Condition. Downloadable and Editable Design and Development Document Templates. Practical Implementation Techniques and Best Practices. This handbook also covers basic, intermediate and advanced design control topics and is an ideal resource for implementing new design control processes or upgrading existing process into medical device quality systems.
Case Studies. As an added bonus, web access to downloadable and editable design control documents are included with this purchase.
Handbook of Human Factors in Medical Device DesignCRC Press #ad - The book also presents a listing of resources, literature, and website references. It offers guidance on user-centric design supported by discussions of design issues, case studies, and examples. Adapted in part from established design standards and conventions, the design guidance presented in this work distills professional judgment extracted from the contributing authors’ years of experience in applied analysis and design.
Cambridge University Press. It not only focuses on the human factors issues that arise when developing medical devices, it supplies the necessary guidance to resolve them. Most chapters begin with a general introduction to the selected topic, followed by the presentation of general and special design considerations and then specific, numbered design guidelines.
Handbook of Human Factors in Medical Device Design #ad - Used book in Good Condition. It then focuses on applied design issues, offering guidance on the design of specific types of devices and designing devices for particular use environments. Used book in Good Condition. Written in true handbook style, illustrations, and cross references, each chapter stands alone and includes tables, allowing you to quickly find the exact information you need.
The book sets the foundation with coverage of fundamental topics such as aligning the interactive nature of medical devices to the expected use environments ranging from hospitals and ambulances to patients’ homes, drawing on anthropometric and biomechanical data to ensure that designs match the intended users’ bodies and physical abilities, and conducting usability tests and other evaluations to ensure that devices perform as intended.
Usability Testing of Medical DevicesCRC Press #ad - Interpretation of design Control Regulation 21 CFR 82030 Cambridge University Press. Downloadable and Editable Design and Development Document Templates. Practical Implementation Techniques and Best Practices. Since publication of the first edition, the FDA and other regulatory groups have modified their regulations and expectations regarding how medical device manufacturers should approach usability testing.
The book also discusses the government regulations and industry standards that motivate many medical device manufacturers to conduct usability tests. Written by seasoned human factors specialists, practical, Second Edition is an informative, Usability Testing of Medical Devices, and up-to-date handbook for conducting usability tests of medical devices.
Usability Testing of Medical Devices #ad - Case Studies. Crc press. The book helps ensure a smooth and painless development process―and thus, safe and effective medical devices. Reflecting these changes, this Second Edition provides updated guidance to readers with an interest or direct role in conducting a usability test of a medical device or system.
Usability testing of medical Devices covers the nitty-gritty of usability test planning, conducting, and results reporting. Used book in Good Condition. Used book in Good Condition. Key updates involve the 2011 fda guidance on human factors engineering, linking usability test tasks to risk analysis results, requirements set forth by the third edition of IEC 60601 and closely related IEC 62366-1:2015, and analyzing root causes of use errors that occur during usability tests.
Medical Device Development: Regulation and LawParexel Intl Corp #ad - New statutory provisions and guidances related to mobile medical apps and medical device software, including medical data software systems. Changes to the 510k premarket notification process, including new policies on split predicates, when a device cannot be found to be SE, and the new priority review guidance.
Updates on the new organizational structure of cdrH, including revisions to the structure of the Office of Device Evaluation the Office of Compliance, and the Office of In Vitro Diagnostics and Radiological Health. Crc press. Used book in Good Condition. The 2014 edition of this popular and authoritative resource reviews and analyzes the following critical developments since the 2009 edition: * Update on all the new provisions of the Food and Drug Administration Safety and Improvement Act of 2012 FDASIA.
Medical Device Development: Regulation and Law #ad - Downloadable and Editable Design and Development Document Templates. Update on the investigational device exemption process, design considerations for pivotal clinical device investigations, FDA decisions for IDE investigations, including new guidances on early feasibility studies, and good laboratory practices.
New statutory provisions and guidances related to device reclassification, Section 522 postmarket surveillance, the CDRH appeal process, humanitarian devices, and custom devices. Used book in Good Condition. Changes to the premarket approval application process, including birth of the e-copy and modifications to the advisory panel process.
Medical device development: regulation and Law, 2014 Edition, is the ''must-have'' resource for the novice or veteran medical device regulatory affairs professional.
Medical Device Marketing: Strategies, Gameplans & Resources for Successful Product ManagementOutskirts Press #ad - Tactics for managing existing product lines-and how to boost sales during a plateau. Cambridge University Press. Effective sales support-including what you really need to know about how every sales team operates. Case Studies. Keys to product development-along with what to do when the unexpected happens. Insider advice for a successful career-and the key behaviors you must always, absolutely avoid in order to keep it.
Used book in Good Condition. Interpretation of design Control Regulation 21 CFR 82030 Steps to a winning business plan-from conducting insightful market research to making accurate cost projections. That's where Medical Device Marketing comes in. The insider's guide to success in this Unique IndustryTo make it in the competitive and fast-changing medical device industry, you need to be armed with the best information available.
Medical Device Marketing: Strategies, Gameplans & Resources for Successful Product Management #ad - . It's packed with real-life examples, sample charts and marketing plans, and-most importantly-keen insight you won't find anywhere else. Used book in Good Condition. How to get product launches right-as well as the communication tips that will make or break a great product. You'll learn: •how to identify the customer-and why this seemingly simple task is trickier than it sounds.