Guidelines For Failure Modes And Effects Analysis For Medical Devices

Author : Dyadem Press
Publisher : CRC Press
ISBN 13 : 0203490118
Total Pages : 190 pages
Book Rating : 4.12/5 ( download)

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Download or read book Guidelines for Failure Modes and Effects Analysis for Medical Devices written by Dyadem Press and published by CRC Press. This book was released on 2018-06-28 with total page 190 pages. Available in PDF, EPUB and Kindle. Book excerpt: Challenged by stringent regulations, vigorous competition, and liability lawsuits, medical device manufactures must develop safe, reliable, and cost-effective products, and managing and reducing risk is a vital element of reaching that goal. A practical guide to achieving corporate consistency while dramatically cutting the time required for studies, Guidelines for Failure Modes and Effects Analysis for Medical Devices focuses on Failure Modes and Effects Analysis (FMEA) and its application throughout the life cycle of a medical device. It outlines the major U.S. and E.U. standards and regulations and provides a detailed yet easy-to-read overview of risk management and risk analysis methodologies, common FMEA pitfalls, and FMECA-Failure Mode, Effects, and Criticality Analysis. Discover how the FMEA methodology can help your company achieve a more cost-effective manufacturing process by improving the quality and reliability of your products. This new FMEA manual from the experts at Dyadem is the ultimate resource for you and your colleagues to learn more about Failure Modes and Effects Analysis and then teach others at your facility. This comprehensive manual is sure to become a standard reference for engineering professionals.

Author : D. H. Stamatis
Publisher : Quality Press
ISBN 13 : 0873895983
Total Pages : 633 pages
Book Rating : 4.89/5 ( download)

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Download or read book Failure Mode and Effect Analysis written by D. H. Stamatis and published by Quality Press. This book was released on 2003-01-01 with total page 633 pages. Available in PDF, EPUB and Kindle. Book excerpt: Author D. H. Stamatis has updated his comprehensive reference book on failure mode and effect analysis (FMEA). This is one of the most comprehensive guides to FMEA and is excellent for professionals with any level of understanding. This book explains the process of conducting system, design, process, service, and machine FMEAs, and provides the rationale for doing so. Readers will understand what FMEA is, the different types of FMEA, how to construct an FMEA, and the linkages between FMEA and other tools. Stamatis offer a summary of tools/methodologies used in FMEA along with a glossary to explain key terms and principles. the updated edition includes information about the new ISO 9000:2000 standard, the Six Sigma approach to FMEA, a special section on automotive requirements related to ISO/TS 16949, the orobustnesso concept, and TE 9000 and the requirements for reliability and maintainability. the accompanying CD-ROM offers FMEA forms and samples, design review checklist, criteria for evaluation, basic reliability formulae and conversion failure factors, guidelines for RPN calculations and designing a reasonable safe product, and diagrams, and examples of FMEAs with linkages to robustness.

Author : Basem El-Haik
Publisher : John Wiley & Sons
ISBN 13 : 1118210417
Total Pages : 528 pages
Book Rating : 4.13/5 ( download)

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Download or read book Medical Device Design for Six Sigma written by Basem El-Haik and published by John Wiley & Sons. This book was released on 2011-09-20 with total page 528 pages. Available in PDF, EPUB and Kindle. Book excerpt: The first comprehensive guide to the integration of Design forSix Sigma principles in the medical devices development cycle Medical Device Design for Six Sigma: A Road Map for Safetyand Effectiveness presents the complete body of knowledge forDesign for Six Sigma (DFSS), as outlined by American Society forQuality, and details how to integrate appropriate designmethodologies up front in the design process. DFSS helps companiesshorten lead times, cut development and manufacturing costs, lowertotal life-cycle cost, and improve the quality of the medicaldevices. Comprehensive and complete with real-world examples, thisguide: Integrates concept and design methods such as Pugh ControlledConvergence approach, QFD methodology, parameter optimizationtechniques like Design of Experiment (DOE), Taguchi Robust Designmethod, Failure Mode and Effects Analysis (FMEA), Design for X,Multi-Level Hierarchical Design methodology, and Response Surfacemethodology Covers contemporary and emerging design methods, includingAxiomatic Design Principles, Theory of Inventive Problem Solving(TRIZ), and Tolerance Design Provides a detailed, step-by-step implementation process foreach DFSS tool included Covers the structural, organizational, and technical deploymentof DFSS within the medical device industry Includes a DFSS case study describing the development of a newdevice Presents a global prospective of medical device regulations Providing both a road map and a toolbox, this is a hands-onreference for medical device product development practitioners,product/service development engineers and architects, DFSS and SixSigma trainees and trainers, middle management, engineering teamleaders, quality engineers and quality consultants, and graduatestudents in biomedical engineering.

Author : Sarfaraz K. Niazi
Publisher : CRC Press
ISBN 13 : 1420081276
Total Pages : 369 pages
Book Rating : 4.75/5 ( download)

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Download or read book Handbook of Pharmaceutical Manufacturing Formulations written by Sarfaraz K. Niazi and published by CRC Press. This book was released on 2016-04-19 with total page 369 pages. Available in PDF, EPUB and Kindle. Book excerpt: The fourth volume in the series covers the techniques and technologies involved in the preparation of semisolid products such as ointments, creams, gels, suppositories, and special topical dosage forms. Drug manufacturers need a thorough understanding of the specific requirements that regulatory agencies impose on the formulation and efficacy deter

Author : B.S. Dhillon
Publisher : CRC Press
ISBN 13 : 1420042238
Total Pages : 265 pages
Book Rating : 4.38/5 ( download)

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Download or read book Medical Device Reliability and Associated Areas written by B.S. Dhillon and published by CRC Press. This book was released on 2000-03-29 with total page 265 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 vital that the engineering, biomedical, manufacturing,

Author : Dean H. Stamatis
Publisher : Quality Press
ISBN 13 : 1951058704
Total Pages : 113 pages
Book Rating : 4.08/5 ( download)

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Download or read book Risk Management Using Failure Mode and Effect Analysis (FMEA) written by Dean H. Stamatis and published by Quality Press. This book was released on 2019-01-18 with total page 113 pages. Available in PDF, EPUB and Kindle. Book excerpt: Risk is everywhere. It does not matter where we are or what we do. It affects us on a personal level, but it also affects us in our world of commerce and our business. This indispensable summary guide is for everyone who wants some fast information regarding failures and how to deal with them. It explores the evaluation process of risk by utilizing one of the core methodologies available: failure modes and effects analysis (FMEA). The intent is to make the concepts easy to understand and explain why FMEA is used in many industries with positive results to either eliminate or mitigate risk.

Author : Sarfaraz K. Niazi
Publisher : CRC Press
ISBN 13 : 1351593331
Total Pages : 462 pages
Book Rating : 4.35/5 ( download)

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Download or read book Handbook of Pharmaceutical Manufacturing Formulations, Third Edition written by Sarfaraz K. Niazi and published by CRC Press. This book was released on 2019-12-06 with total page 462 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume Four, Semisolid Products is an authoritative and practical guide to the art and science of formulating drugs for commercial manufacturing. With thoroughly revised and expanded content, this fourth volume of a six-volume set, compiles data from FDA and EMA new drug applications, patents and patent applications, and other sources of generic and proprietary formulations including author’s own experience, to cover the broad spectrum of cGMP formulations and issues in using these formulations in a commercial setting. A must-have collection for pharmaceutical manufacturers, educational institutions, and regulatory authorities, this is an excellent platform for drug companies to benchmark their products and for generic companies to formulate drugs coming off patent. Features:  Largest source of authoritative and practical formulations, cGMP compliance guidance and self-audit suggestions  Differs from other publications on formulation science in that it focuses on readily scalable commercial formulations that can be adopted for cGMP manufacturing  Tackles common difficulties in formulating drugs and presents details on stability testing, bioequivalence testing, and full compliance with drug product safety elements  Written by a well-recognized authority on drug and dosage form development including biological drugs and alternative medicines

Author : Douglas J. Ball
Publisher : John Wiley & Sons
ISBN 13 : 0470173653
Total Pages : 702 pages
Book Rating : 4.57/5 ( download)

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Download or read book Leachables and Extractables Handbook written by Douglas J. Ball and published by John Wiley & Sons. This book was released on 2012-01-24 with total page 702 pages. Available in PDF, EPUB and Kindle. Book excerpt: A practical and science-based approach for addressing toxicological concerns related to leachables and extractables associated with inhalation drug products Packaging and device components of Orally Inhaled and Nasal Drug Products (OINDP) such as metered dose inhalers, dry powder inhalers, and nasal sprays pose potential safety risks from leachables and extractables, chemicals that can be released or migrate from these components into the drug product. Addressing the concepts, background, historical use, and development of safety thresholds and their utility for qualifying leachables and extractables in OINDP, the Leachables and Extractables Handbook takes a practical approach to familiarize readers with the recent recommendations for safety and risk assessment established through a joint effort of scientists from the FDA, academia, and industry. Coverage includes best practices for the chemical evaluation and management of leachables and extractables throughout the pharmaceutical product life cycle, as well as: Guidance for pharmaceutical professionals to qualify and risk-assess container closure system leachables and extractables in drug products Principles for defining toxicological safety thresholds that are applicable to OINDP and potentially applicable to other drug products Regulatory perspectives, along with an appendix of key terms and definitions, case studies, and sample protocols Analytical chemists, packaging and device engineers, formulation development scientists, component suppliers, regulatory affairs specialists, and toxicologists will all benefit from the wealth of information offered in this important text.

Author : Jose Justiniano
Publisher : CRC Press
ISBN 13 : 1135506744
Total Pages : 113 pages
Book Rating : 4.42/5 ( download)

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Download or read book Six Sigma for Medical Device Design written by Jose Justiniano and published by CRC Press. This book was released on 2004-11-15 with total page 113 pages. Available in PDF, EPUB and Kindle. Book excerpt: Six Sigma for Medical Device Design is the first book to apply Six Sigma principles to the design of medical devices. Authored by experienced professionals, it uses real world examples and sample plans to provide a practical how-to guide for implementation. This volume also links the Six Sigma philosophy with the FDA's Design Control and ISO regulations, useful for companies that must be compliant as well as for those in the process of implementing a quality system for design control. This book is an excellent tool for technical and scientific personnel to understand the realities of business and markets, to comply with stringent quality and safety standards, and to optimize the product realization process.

Author : Roger L. Brauer
Publisher : John Wiley & Sons
ISBN 13 : 1119802318
Total Pages : 678 pages
Book Rating : 4.10/5 ( download)

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Download or read book Safety and Health for Engineers written by Roger L. Brauer and published by John Wiley & Sons. This book was released on 2022-08-18 with total page 678 pages. Available in PDF, EPUB and Kindle. Book excerpt: SAFETY AND HEALTH FOR ENGINEERS A comprehensive resource for making products, facilities, processes, and operations safe for workers, users, and the public Ensuring the health and safety of individuals in the workplace is vital on an interpersonal level but is also crucial to limiting the liability of companies in the event of an onsite injury. The Bureau of Labor Statistics reported over 4,700 fatal work injuries in the United States in 2020, most frequently in transportation-related incidents. The same year, approximately 2.7 million workplace injuries and illnesses were reported by private industry employers. According to the National Safety Council, the cost in lost wages, productivity, medical and administrative costs is close to 1.2 trillion dollars in the US alone. It is imperative—by law and ethics—for engineers and safety and health professionals to drive down these statistics by creating a safe workplace and safe products, as well as maintaining a safe environment. Safety and Health for Engineers is considered the gold standard for engineers in all specialties, teaching an understanding of many components necessary to achieve safe workplaces, products, facilities, and methods to secure safety for workers, users, and the public. Each chapter offers information relevant to help safety professionals and engineers in the achievement of the first canon of professional ethics: to protect the health, safety, and welfare of the public. The textbook examines the fundamentals of safety, legal aspects, hazard recognition and control, the human element, and techniques to manage safety decisions. In doing so, it covers the primary safety essentials necessary for certification examinations for practitioners. Readers of the fourth edition of Safety and Health for Engineers readers will also find: Updates to all chapters, informed by research and references gathered since the last publication The most up-to-date information on current policy, certifications, regulations, agency standards, and the impact of new technologies, such as wearable technology, automation in transportation, and artificial intelligence New international information, including U.S. and foreign standards agencies, professional societies, and other organizations worldwide Expanded sections with real-world applications, exercises, and 164 case studies An extensive list of references to help readers find more detail on chapter contents A solution manual available to qualified instructors Safety and Health for Engineers is an ideal textbook for courses in safety engineering around the world in undergraduate or graduate studies, or in professional development learning. It also is a useful reference for professionals in engineering, safety, health, and associated fields who are preparing for credentialing examinations in safety and health.