Download or read book Proactive Supplier Management in the Medical Device Industry written by James B. Shore and published by Quality Press. This book was released on 2016-05-06 with total page 108 pages. Available in PDF, EPUB and Kindle. Book excerpt: In order for organizations to have high confidence in the reliability of their medical devices, they must ensure that each and every component or service meets requirements, including quality requirements. In that light, supplier management is not only a regulatory requirement but also a business aspect. The intent of this book is to show readers a process of effectively selecting, evaluating, and implementing applicable controls based on the evaluation and ongoing proactive management of suppliers, consultants, and contractors in a state of compliance. These processes can be applied to all suppliers, consultants, and contractors. In writing this book, the authors made sure that readers could immediately apply its content. They provide best practices based on a combined 50+ years of quality and engineering experience, having worked with some of the best medical device companies and contract manufacturers in the world. Four icons use throughout the book help readers navigate and understand the content. The FDA and toolbox icons assist in determining whether its a requirement or a tool to help achieve compliance. The Lessons from the Road icon indicates real-life stories and what the authors have learned throughout their careers. Lastly, the check mark icon is used to highlight key thoughts, what they feel are unique takeaways or deserve a special focus.
Download or read book The ASQ Certified Supplier Quality Professional Handbook written by Mark Allen Durivage and published by Quality Press. This book was released on 2023-11-15 with total page 323 pages. Available in PDF, EPUB and Kindle. Book excerpt: This handbook explains, in detail, each section of the Certified Supplier Quality Professional Body of Knowledge (updated 2023). It is a handy reference for those already working in the field and is an essential text for those working toward a CSQP certification.
Download or read book Managing Organizational Risk Using the Supplier Audit Program written by Lance B. Coleman, Sr and published by Quality Press. This book was released on 2018-04-06 with total page 115 pages. Available in PDF, EPUB and Kindle. Book excerpt: Risk elimination. Risk management. Risk mitigation. These terms are an increasingly important part of the lexicon of executive-level management as they strive to succeed in a business environment having global competition, geographically diverse suppliers, and new technologies. In this new, globally expansive marketplace, more than 50 percent of value creation is achieved outside of an organizations walls, or, in other words, through their suppliers. This, too, is where the majority of product realization risk lies. This book defines what risk-based thinking is and how to apply it from the perspective of helping manage organizational risk through the supplier audit process. It provides a detailed and useful discussion of the practical application of risk-based supplier auditing principles. It can be a primer for those new to the profession of supplier auditing, and it also shares tips and best practices that would benefit experienced auditors as well. The first section explores supplier management, supplier auditing, and the supplier audit process. The second section discusses the skills, both traditional and nontraditional, needed to ensure a successful supplier audit. Relevant aspects of ASQs Certified Quality Auditor (CQA) and Certified Supplier Quality Professional (CSQP) Bodies of Knowledge are discussed in detail. The authors friends and colleagues from around the globe shared their own stories in Case in Point vignettes interspersed throughout the book, providing first-hand case studies from, among others, the medical device, logistics, automotive, and aerospace industries.
Download or read book Quality Risk Management in the FDA Regulated Industry written by José Rodríguez-Pérez and published by Quality Press. This book was released on 2017-02-21 with total page 252 pages. Available in PDF, EPUB and Kindle. Book excerpt: The purpose of this new edition is to offer an updated view of the risk management field as it applies to medical products. Since the publication of the first edition (2012), the emphasis on risk-based processes has growth exponentially across all sectors, and risk management is now considered as significant as quality management. ISO 9001 was revised and now requires that top management promote the use of risk-based thinking. ISO 13485:2016, which specifies the requirements for a quality management system specific to the medical devices industry, also now shows a greater emphasis on risk management and risk-based decision making. In addition, the FDA Food Safety Modernization Act (FSMA) is the most important reform of U.S. food safety laws in more than 70 years. This indispensable book presents a systematic and comprehensive approach to quality risk management. It will assist medical and food product manufacturers with the integration of a risk management system or risk management principles and activities into their existing quality management system by providing practical explanations and examples. The appropriate use of quality risk management can facilitate compliance with regulatory requirements such as good manufacturing practice or good laboratory practice. All chapters have been updated and revised, and a new chapter has been added to discuss some of the most common pitfalls and misunderstandings regarding risk management, specifically those related to the use of FMEA as the only element of risk management programs. One of the appendices includes 12 case studies, and the companion CD-ROM contains dozens of U.S. FDA and European guidance documents as well as international harmonization documents (ICH and GHTF-IMDRF) related to risk management activities, as well as a 30-question exam (with answers) on the material discussed in the book.
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 RISK MANAGEMENT FOR THE MEDICAL DEVICE INDUSTRY written by Dr. Akash Sharma, Ms. Vriti Gamta , Mr. Gaurav Luthra and published by Notion Press. This book was released on 2023-07-25 with total page 139 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Risk Management for the Medical Device Industry: A Guide based on ISO 14971" is an essential resource for professionals in the fast-paced medical device industry. Authored by Dr. Akash Sharma, Ms. Vriti Gamta, and Mr. Gaurav Luthra, experts in regulatory affairs and quality management systems, this practical guide offers comprehensive insights into risk management and compliance. Covering the entire risk management lifecycle, it includes case studies, best practices, and practical examples, along with discussions on integrating risk management with quality management systems and emerging technologies. Equip yourself with the knowledge and tools to ensure safety and effectiveness in the global market.
Download or read book Supplier Performance Scorecard Utilization in the Medical Device Manufacturing Healthcare Supply Chain written by Justin Cardisco and published by . This book was released on 2022 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The medical device manufacturing industry has a deficiency in determining how to improve supplier performance for the components and systems they purchase. Many complex medical devices require components from superb suppliers. But how does a medical device manufacturer (MDM) impartially assess supplier performance to know which suppliers to continuing with (or even boost purchase volumes) and which suppliers they should exit? This study describes which supplier-specific metrics are most important to medical device manufacturers (MDMs) so they can utilize this supplier performance scorecard backed by real-world inputs. This research will focus on five categories to measure MDM supplier performance (Quality, Price, Delivery, Customer Service, and Partnership) across twenty-three (23) metrics. Because this is a focus of MDM supplier performance, we are not focusing on analysis of device sales to the final customer (e.g., distributors or group purchasing organizations {GPO}). The study will follow a framework including research analysis of supplier performance management in other industries, methods to attain data from MDMs via survey, results and analysis of the data, conclusions, and an easily understandable MDM supplier performance scorecard. In the survey, 135 MDM professionals replied when asked to rate twenty-three (23) supplier performance metrics, across five (5) categories aggregated from nine (9) different industries. The survey yielded a myriad of results including, weighting factors of each of the metrics, and those data results were used to compile an MDM supplier performance scorecard utilizing real-world feedback. The analysis revealed the ratings of importance of the categories as: Quality (43%), Delivery (24%), Customer Service (4%), Partnership (13%), Price (8%) and associated weights for the twenty-three (23) metrics that matter most to an MDM when creating a performance scorecard for their supplier base. Three contributions that this research will add to the body of knowledge: 1) An in-depth review of supplier performance across many different industries (i.e., non-healthcare and healthcare) for contrasting/comparing evidence. 2) A detailed MDM survey and statistical analysis on the topic of supplier performance management. 3) An easily understandable and useable MDM supplier performance scorecard (via MS Excel) for MDM supply chain and/or operations users and/or managers.
Download or read book The ASQ Certified Manager of Quality Organizational Excellence Handbook written by Sandra L Furterer and published by Quality Press. This book was released on 2021-01-25 with total page 555 pages. Available in PDF, EPUB and Kindle. Book excerpt: This handbook is a comprehensive reference designed to help professionals address organizational issues from the application of the basic principles of management to the development of strategies needed to deal with today’s technological and societal concerns. The fifth edition of the ASQ Certified Manager of Quality/Organizational Excellence Handbook (CMQ/OE) has undergone some significant content changes in order to provide more clarity regarding the items in the body of knowledge (BoK). Examples have been updated to reflect more current perspectives, and new topics introduced in the most recent BoK are included as well. This handbook addresses: • Historical perspectives relating to the continued improvement of specific aspects of quality management • Key principles, concepts, and terminology • Benefits associated with the application of key concepts and quality management principles • Best practices describing recognized approaches for good quality management • Barriers to success, common problems you may encounter, and reasons why some quality initiatives fail • Guidance for preparation to take the CMQ/OE examination A well-organized reference, this handbook will certainly help individuals prepare for the ASQ CMQ/OE exam. It also serves as a practical, day-to-day guide for any professional facing various quality management challenges.
Download or read book Innovation Management in the Intelligent World written by Tugrul U. Daim and published by Springer Nature. This book was released on 2020-12-17 with total page 322 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book introduces readers to state-of-the-art cases and tools for managing innovation in today’s rapidly changing business environment. It provides a wealth of methodological knowhow and guidance on practical applications, as well as case studies that reveal various challenges in technology and innovation management. Written by a mix of academic scholars and practitioners, the respective chapters present tools and approaches for the early detection of emerging fields of innovation, as well as relevant processes and resources. The contributing authors hail from leading innovative companies including Google, Amazon, Intel, Daimler-Benz, and NASA.
Download or read book Risk Based Quality Management in Healthcare Organization written by Dr. Akash Sharma, Ms. Vriti Gamta, Mr.Gaurav Luthra and published by Notion Press. This book was released on 2023-08-09 with total page 105 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Risk-Based Quality Management in Healthcare Organization: A Guide based on ISO 13485 and EU MDR" is a comprehensive handbook that offers practical guidance for healthcare professionals to excel in risk-based quality management. It explores the regulatory landscape of the healthcare industry, emphasizing ISO 13485 and EU MDR as the foundation. The book provides a step-by-step approach to implementing effective risk assessment and mitigation strategies, ensuring compliance with international standards. It includes best practices to navigate risk management throughout the medical device lifecycle. The guide also addresses integrating risk management into existing quality management systems, conducting audits, and meeting EU MDR requirements. By mastering the principles in this guide, professionals can enhance patient safety, improve product quality, and achieve regulatory compliance. It is a valuable resource for healthcare professionals involved in device design, manufacturing, testing, and regulatory affairs.
Download or read book The Combination Products Handbook written by Susan Neadle and published by CRC Press. This book was released on 2023-05-16 with total page 439 pages. Available in PDF, EPUB and Kindle. Book excerpt: Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. According to the US Food and Drug Administration (FDA), “a combination product is one composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device and a biological product.” Examples include prefilled syringes, pen injectors, autoinjectors, inhalers, transdermal delivery systems, drug-eluting stents, and kits containing drug administration devices co-packaged with drugs and/or biological products. This handbook provides the most up-to-date information on the development of combination products, from the technology involved to successful delivery to market. The authors present important and up-to-the-minute pre- and post-market reviews of international combination product regulations, guidance, considerations, and best practices. This handbook: Brings clarity of understanding for global combination products guidance and regulations Reviews the current state-of-the-art considerations and best practices spanning the combination product lifecycle, pre-market through post-market Reviews medical product classification and assignment issues faced by global regulatory authorities and industry The editor is a recognized international Combination Products and Medical Device expert with over 35 years of industry experience and has an outstanding team of contributors. Endorsed by AAMI – Association for the Advancement of Medical Instrumentation.
Download or read book Supply Chain Management in the Drug Industry written by Hedley Rees and published by John Wiley & Sons. This book was released on 2011-04-06 with total page 458 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book bridges the gap between practitioners of supply-chain management and pharmaceutical industry experts. It aims to help both these groups understand the different worlds they live in and how to jointly contribute to meaningful improvements in supply-chains within the globally important pharmaceutical sector. Scientific and technical staff must work closely with supply-chain practitioners and other relevant parties to help secure responsive, cost effective and risk mitigated supply chains to compete on a world stage. This should not wait until a drug has been registered, but should start as early as possible in the development process and before registration or clinical trials. The author suggests that CMC (chemistry manufacturing controls) drug development must reset the line of sight – from supply of drug to the clinic and gaining a registration, to the building of a patient value stream. Capable processes and suppliers, streamlined logistics, flexible plant and equipment, shorter cycle times, effective flow of information and reduced waste. All these factors can and should be addressed at the CMC development stage.
Download or read book Inspection of Medical Devices written by Almir Badnjević and published by Springer Nature. This book was released on 2023-12-28 with total page 441 pages. Available in PDF, EPUB and Kindle. Book excerpt: This comprehensive guide invites nations worldwide to embark on a transformative journey, implementing independent third-party verification systems that ensure medical devices comply with both international and national regulations. Prepare to be captivated as we delve into the intricate processes, unveil essential procedures, and illuminate the paramount importance of establishing traceability for medical device measurements. Imagine a world where medical devices undergo rigorous independent safety and performance verification, guaranteeing the utmost reliability for patient diagnoses and treatment. This book takes you on a compelling exploration of precisely that vision. Focusing on cutting-edge diagnostic and therapeutic devices, it captures the very essence of the latest international directives and regulations, ensuring you stay ahead of the curve. This new edition goes beyond the conventional, delving into the realms of innovation and progress. Unveiling in-depth maintenance regimes within healthcare institutions, we provide you with invaluable insights into post-market surveillance. As the world embraces the transformative potential of artificial intelligence, we pave the way for evidence-based management of medical device maintenance—a concept poised to reshape the healthcare landscape. Imagine a future where medical devices are seamlessly integrated into the legal metrology system, while fully operational national laboratories for medical device inspection set new standards of excellence. This book vividly illustrates how such a powerful union can elevate the reliability of medical devices in diagnosis and patient care. Brace yourself for a paradigm shift that not only enhances efficacy but also leads to significant cost reductions within your country's healthcare system. Join us on this extraordinary journey as we unveil the untapped potential of medical device inspection. With our innovative approach and unrivaled expertise, together we can revolutionize healthcare, transforming the lives of countless patients worldwide. Get ready to be inspired, informed, and empowered—welcome to the future of healthcare!
Download or read book The Procurement and Supply Manager s Desk Reference written by Fred Sollish and published by John Wiley & Sons. This book was released on 2007-07-20 with total page 483 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Procurement and Supply Manager's Desk Reference "Finally, a cohesive volume written for the worldwide profession of purchasing and supply chain management." —James D. Reeds, CPM, CFPIM, CIRM, CPCM, President, Institute for Supply Management-Silicon Valley "Great resource. This work is educational, informative, and certainly, most practical." —Peter Sterlacci, Director, Professional Development, San Jose State University "Complete with useful information-the authors are extraordinary experts in the field of supply chain management." —Michael Geraghty, MBA, President, Geraghty International, and author of Anybody Can Negotiate—Even You! Destined to become every supply manager's essential desktop tool with in-depth, authoritative coverage of each topic Leaving no stone unturned in covering all aspects of the purchasing and sourcing function, The Procurement and Supply Manager's Desk Reference is filled with everything every supply manager needs to know about the key roles and responsibilities of a procurement manager. Filled with practical aids such as checklists and customizable forms, this essential book provides an easy-to-use road map for the supply manager in the new millennium. With an eye toward incorporating proactive strategies and best practices, The Procurement and Supply Manager's Desk Reference offers detailed coverage and tips on: Procurement and Best Business Practices Sourcing Management How to select suppliers and measure performance The best way to leverage computer systems Providing value to the organization Identifying those strategies that will work best for your business for years to come
Download or read book Medical Device Design and Regulation written by Carl T. DeMarco and published by Quality Press. This book was released on 2011-01-01 with total page 369 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The Medical Device Industry written by John Burton and published by Cambridge Scholars Publishing. This book was released on 2009-03-26 with total page 200 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Medical Device industry is one of the fastest growing industries in the world. Device manufacturers are producing increasingly sophisticated and complex medical device software to differentiate themselves in the battle for dominance in this sector. The increase in the complexity of medical device software has introduced new challenges with respect to making medical devices and their associated software safe. Risk management has emerged as key in addressing these challenges. Existing literature on risk management for medical devices has been slow to adequately account for the complex nature of software in modern medical devices. Conversely, excellent progress has been made in the broader Software Engineering community with the production of holistic software risk based models such as the Capability Maturity Model Integration (CMMI®) and SPICE™. However, these models do not account for medical device specific requirements. This book examines the possibility of a unified approach whilst investigating the relevance of the CMMI® SPI model to the medical device regulatory requirements.
Download or read book The Medical Device R D Handbook Second Edition written by Theodore R. Kucklick and published by CRC Press. This book was released on 2012-12-05 with total page 513 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 author discusses the historical background of various technologies, helping readers understand how and why certain devices were developed. 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. This updated and expanded edition adds new information to help meet the challenges of the medical device industry, including strategic intellectual property management, operating room observation protocol, and the use of new technologies and new materials in device development.
