Download or read book Pre Production Quality Assurance for Healthcare Manufacturers written by G. William Hough and published by CRC Press. This book was released on 1997-06-30 with total page 296 pages. Available in PDF, EPUB and Kindle. Book excerpt: The FDA and ISO 9001 require manufacturers to institute comprehensive and rigorous pre-production quality assurance processes to assure that design defects will be eliminated prior to manufacture and product sale. Pre-Production Quality Assurance for Healthcare Manufacturers addresses the product design and development phases for a medical product life cycle and shows how this effort can be successfully undertaken in accord with current Good Practice and ISO 9001. The authors provide a detailed step-by-step approach to ensuring that effective pre-production quality assurance is established and effectively in place and explore the key concepts of design, product, and process.
Download or read book Medical Technology written by United States. General Accounting Office and published by . This book was released on 1992 with total page 104 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Reliability Technology Human Error and Quality in Health Care written by B.S. Dhillon and published by CRC Press. This book was released on 2008-02-21 with total page 212 pages. Available in PDF, EPUB and Kindle. Book excerpt: The effective and interrelated functioning of system reliability technology, human factors, and quality play an important role in the appropriate, efficient, and cost-effective delivery of health care. Simply put, it can save you time, money, and more importantly, lives. Over the years a large number of journal and conference proceedings articles o
Download or read book Preproduction Quality Assurance Planning written by and published by . This book was released on 1989 with total page 18 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Medical Devices Bulletin written by and published by . This book was released on with total page 872 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The Medical Device Industry written by Norman F. Estrin and published by CRC Press. This book was released on 1990-08-31 with total page 1020 pages. Available in PDF, EPUB and Kindle. Book excerpt: Practical information about the complexities of biomedical technology and regulation, and their implications for manufacturers and marketers of health care devices. Written primarily for those in the industry concerned about staying competitive in light of complex and fluctuating regulatory approach
Download or read book Uncertainty in Strategic Decision Making written by Richard J. Arend and published by Springer Nature. This book was released on 2024-01-03 with total page 466 pages. Available in PDF, EPUB and Kindle. Book excerpt: Knight (1921) defines uncertainty as an informational market failure that, while being detrimental to most existing businesses, presents possible profitable opportunities for others. This book builds upon that classic work by providing an analysis of the alternative approaches to strategic decision-making under such uncertainty. It covers what uncertainty is, why it is important, and what connections it has to business and related fields, culminating in a new and comprehensive typology and a valuable guide for how to appropriately address various types of uncertainties, even under AI. It clarifies the current terminological and categorical confusion about ‘unknowns’ while complementing the mathematical, probability-based approaches that treat uncertainty as ‘knowable’ (i.e., as risk). It corrects the mistaken approaches that treat ‘unknowables’ as ‘shapeable’ or ‘discoverable’. This book widens the perspective for viewing uncertainty, in terms of its impacts across humanity, by offering a shrewder understanding of what roles uncertainties play in human activity. It will appeal to academics across business, economics, philosophy, and other disciplines looking for approaches to apply, test, and hone for dealing with decision-making under uncertainty.
Download or read book Quality Control Applications in the Pharmaceutical and Medical Device Manufacturing Industry written by Eugenia Gabriela Carrillo-Cedillo and published by . This book was released on 2022 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: "This book gives the reader an up-to-date overview of the medical device manufacturing process and its influence on current regulations highlighting the importance of quality control in pharmaceutical products and medical devices, which must have very high-quality standards so as not to cause problems to the health of patients"--
Download or read book Quality Control Applications in the Pharmaceutical and Medical Device Manufacturing Industry written by Carrillo-Cedillo, Eugenia Gabriela and published by IGI Global. This book was released on 2022-03-18 with total page 298 pages. Available in PDF, EPUB and Kindle. Book excerpt: Quality control in pharmaceutical products and medical devices is vital for users as failing to comply with national and international regulations can lead to accidents that could easily be avoided. For this reason, manufacturing a quality medical product will support patient safety. Microbiologists working in both the pharmaceutical and medical device industries face considerable challenges in keeping abreast of the myriad microbiological references available to them and the continuously evolving regulatory requirements. Quality Control Applications in the Pharmaceutical and Medical Device Manufacturing Industry presents the importance of quality control in pharmaceutical products and medical devices, which must have very high-quality standards to not cause problems to the health of patients. It reinforces and updates the knowledge of analytical, instrumental, and biological methods to demonstrate the correct quality control and good manufacturing practice for pharmaceutical products and medical devices. Covering topics such as pharmaceutical nano systems, machine learning, and software validation, this book is an essential resource for managers, engineers, supervisors, pharmacists, chemists, academicians, and researchers.
Download or read book Quality in the Manufacture of Medicines and Other Healthcare Products written by John Sharp and published by . This book was released on 2000 with total page 536 pages. Available in PDF, EPUB and Kindle. Book excerpt: This overview of quality assurance in pharmaceutical production describes the principles and practice, and discusses specific quality issues, providing a guide to both national and internatinal regulatory requirements.
Download or read book Control of Particulate Matter Contamination in Healthcare Manufacturing written by Thomas A. Barber and published by CRC Press. This book was released on 1999-10-31 with total page 579 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written by an expert in the industry, this text addresses the specifics of contamination, including particle origination, characterization, identification, and elimination, with a special focus on quality. The author offers a clear and concise review of particle populations and their control in stability, efficacy, and predictability in the manufacture of healthcare products. He brings together information from over 100 Web sites and other sources and casts it into a practical framework that will help readers ensure their company's success. The book contains thirty-two color photomicrographs and over eighty figures, tables, and charts.
Download or read book The Biomedical Quality Auditor Handbook Third Edition written by Heather Crawford and published by Quality Press. This book was released on 2017-09-08 with total page 271 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Biomedical Quality Auditor Handbook was developed by the ASQ Biomedical Division in support of its mission to promote the awareness and use of quality principles, concepts, and technologies in the biomedical community. This third edition correlates to the 2013 exam Body of Knowledge (BoK) and reference list for ASQs Certified Biomedical Auditor program. It includes updates and corrections to errors and omissions in the second edition. Most notably it has been re-organized to align more closely with the BoK.
Download or read book Handbook of Polymer Applications in Medicine and Medical Devices written by Kayvon Modjarrad and published by Elsevier. This book was released on 2013-12-05 with total page 365 pages. Available in PDF, EPUB and Kindle. Book excerpt: While the prevalence of plastics and elastomers in medical devices is now quite well known, there is less information available covering the use of medical devices and the applications of polymers beyond medical devices, such as in hydrogels, biopolymers and silicones beyond enhancement applications, and few books in which these are combined into a single reference. This book is a comprehensive reference source, bringing together a number of key medical polymer topics in one place for a broad audience of engineers and scientists, especially those currently developing new medical devices or seeking more information about current and future applications. In addition to a broad range of applications, the book also covers clinical outcomes and complications arising from the use of the polymers in the body, giving engineers a vital insight into the real world implications of the devices they’re creating. Regulatory issues are also covered in detail. The book also presents the latest developments on the use of polymers in medicine and development of nano-scale devices. Gathers discussions of a large number of applications of polymers in medicine in one place Provides an insight into both the legal and clinical implications of device design Relevant to industry, academic and medical professionals Presents the latest developments in the field, including medical devices on a nano-scale
Download or read book Pharmaceutical Dosage Forms written by Kenneth E. Avis and published by Routledge. This book was released on 2018-05-04 with total page 565 pages. Available in PDF, EPUB and Kindle. Book excerpt: Completely updated and enlarged to three volumes (originally published as two volumes), the Second Edition of Pharmaceutical Dosage Forms: Parenteral Medications examines every important aspect of sterile drug products. This volume (3) offers comprehensive coverage of medical devices, quality assurance and regulatory issues.;This in-depth reference and text: discusses regulatory requirements in record-keeping based on the US Food and Drug Administration's (FDA) Current Good Manufacturing Practices; places special emphasis on methods of detecting, counting and sizing particles; offers new perspectives on contemporary validation concepts and how they affect the validation process; explains current FDA enforcement activities, the voluntary compliance policy, select court cases, and how these relate to parenterals; provides recent materials on the use of audits as a means of verifying the efficacy of manufacturing control systems; highlights new US regulations for medical devices; and examines quality assurance, including new information on biological control tests for medical device materials.;With the contributions of leading experts, volume 3 of Pharmaceutical Dosage Forms: Parenteral Medications is intended as a day-to-day reference for pharmacists, medical device manufacturers, quality control and regulatory personnel, chemists and drug patent and litigation attorneys, as well as a text for upper-level undergraduate, graduate and continuing-education students in the pharmaceutical sciences.
Download or read book Manufacturing Advantage written by Eileen Appelbaum and published by Cornell University Press. This book was released on 2000 with total page 286 pages. Available in PDF, EPUB and Kindle. Book excerpt: Much of the hoopla surrounding quality circles, teams, and high-performance work systems has been based on anecdotes and very thin evidence. It has not been established that those employee involvement strategies amount to anything more than another series of management fads or ruses designed to get more out of workers without giving them anything in return. This revelatory book, written by some of the skeptics, lays some of the suspicion to rest. Based on their visits to 44 plants and surveys of more than 4,000 employees, Eileen Appelbaum, Thomas Bailey, Peter Berg, and Arne L. Kalleberg concluded that companies are indeed more successful when managers share knowledge and power with workers and when workers assume increased responsibility and discretion. The study of steel, apparel, and medical electronics and imaging plants revealed much. In self-directed teams, workers were able to eliminate bottlenecks and coordinate the work process. In task forces created to improve quality, they communicated with individuals outside their own work groups and were able to solve problems. Expensive equipment in steel mills operated with fewer interruptions, turnaround and labor costs were cut in apparel factories, and costly inventories of components and medical equipment were reduced. And what did the employees think? The worker survey showed that jobs in participatory work systems often provide more challenging tasks and more opportunities for creativity. Employees in apparel had higher hourly earnings; those in steel had both higher hourly earnings and higher job satisfaction. Workers in more participatory settings were no more likely than others to report heavy workloads or excessive demands on their time. They were, however, less likely to report involuntary overtime or conflict with co-workers, and were more likely to be satisfied with their surroundings. Manufacturing Advantage provides the best assessment available of the effectiveness of high-performance work systems. Freestanding chapters near the end of the book provide full documentation of research data without interrupting the narrative flow.
Download or read book Plastics in Medical Devices written by Vinny R. Sastri and published by Elsevier. This book was released on 2010-03-05 with total page 289 pages. Available in PDF, EPUB and Kindle. Book excerpt: No book has been published that gives a detailed description of all the types of plastic materials used in medical devices, the unique requirements that the materials need to comply with and the ways standard plastics can be modified to meet such needs. This book will start with an introduction to medical devices, their classification and some of the regulations (both US and global) that affect their design, production and sale. A couple of chapters will focus on all the requirements that plastics need to meet for medical device applications. The subsequent chapters describe the various types of plastic materials, their properties profiles, the advantages and disadvantages for medical device applications, the techniques by which their properties can be enhanced, and real-world examples of their use. Comparative tables will allow readers to find the right classes of materials suitable for their applications or new product development needs.
Download or read book Design of Biomedical Devices and Systems 4th edition written by Paul H. King and published by CRC Press. This book was released on 2018-10-03 with total page 508 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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