Proactive Supplier Management In The Medical Device Industry

Author : James B. Shore,John A. Freije
Publisher : Quality Press
Page : 132 pages
File Size : 52,9 Mb
Release : 2016-04-27
Category : Business & Economics
ISBN : 9781953079664

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Proactive Supplier Management in the Medical Device Industry by James B. Shore,John A. Freije Pdf

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 it's 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.

Author : Mark Allen Durivage,Stephanie L. Parker
Publisher : Quality Press
Page : 323 pages
File Size : 47,8 Mb
Release : 2023-11-15
Category : Business & Economics
ISBN : 9781636941219

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The ASQ Certified Supplier Quality Professional Handbook by Mark Allen Durivage,Stephanie L. Parker Pdf

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.

Author : Lance B. Coleman, Sr
Publisher : Quality Press
Page : 117 pages
File Size : 53,8 Mb
Release : 2018-04-06
Category : Business & Economics
ISBN : 9780873899680

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Managing Organizational Risk Using the Supplier Audit Program by Lance B. Coleman, Sr Pdf

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 organization’s 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 ASQ’s Certified Quality Auditor (CQA) and Certified Supplier Quality Professional (CSQP) Bodies of Knowledge are discussed in detail. The author’s 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.

Author : José Rodríguez-Pérez
Publisher : Quality Press
Page : 252 pages
File Size : 47,5 Mb
Release : 2017-02-21
Category : Business & Economics
ISBN : 9781953079329

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Quality Risk Management in the FDA-Regulated Industry by José Rodríguez-Pérez Pdf

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.

Author : Heather Crawford
Publisher : Quality Press
Page : 300 pages
File Size : 48,5 Mb
Release : 2017-09-08
Category : Business & Economics
ISBN : 9780873899628

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The Biomedical Quality Auditor Handbook, Third Edition by Heather Crawford Pdf

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 ASQ’s 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.

Author : Carl T. DeMarco
Publisher : Quality Press
Page : 369 pages
File Size : 53,8 Mb
Release : 2011-01-01
Category : Business & Economics
ISBN : 9780873898164

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Medical Device Design and Regulation by Carl T. DeMarco Pdf

Author : Dr. Akash Sharma, Ms. Vriti Gamta , Mr. Gaurav Luthra
Publisher : Notion Press
Page : 139 pages
File Size : 52,6 Mb
Release : 2023-07-25
Category : Medical
ISBN : 9798890668295

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RISK MANAGEMENT FOR THE MEDICAL DEVICE INDUSTRY by Dr. Akash Sharma, Ms. Vriti Gamta , Mr. Gaurav Luthra Pdf

"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.

Author : Eugene S. Schneller,James Eckler,Yousef Abdulsalam,Karen Conway
Publisher : John Wiley & Sons
Page : 390 pages
File Size : 55,5 Mb
Release : 2023-08-15
Category : Medical
ISBN : 9781119908449

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Strategic Management of the Health Care Supply Chain by Eugene S. Schneller,James Eckler,Yousef Abdulsalam,Karen Conway Pdf

A systems approach to understanding the needs of today’s healthcare supply chain Strategic Management of the Healthcare Supply Chain offers a big-picture overview and a proven strategic framework for supply chain management in healthcare. It also addresses concrete strategies for risk management, partnerships, logistics, performance assessment, information technology, and beyond. Readers will gain a comprehensive understanding of the issues facing the healthcare supply chain and the opportunities that present themselves as we look toward the future. Written by a team of authors with both research expertise and practical experience in healthcare supply chain, this broad and impactful book teases out the complexities within the supply chain field and the healthcare ecosystem. The healthcare industry is evolving rapidly, and the role of the supply chain is shifting in response. Institutions and practitioners are collaborating more closely than ever with supply chain leaders. This shift introduces new opportunities and challenges at the level of healthcare delivery. Additionally, the role of supply chain in safeguarding the social determinants of health—food, transportation, critical health-related products—is rapidly expanding, especially in historically underserved populations. This revised edition takes a holistic approach to the needs of people and organizations, yielding strategies that will improve both economic and health outcomes. Gain the understanding you need to work toward building a mature supply chain organization Develop perspective on how the needs of the healthcare supply chain are shifting in the modern era Holistically assess supply chain performance and improve clinical, financial, and operational outcomes Identify opportunities to generate value, improve alliances, and cut costs This book will be of interest to graduate students in the health sector and supply chain programs, as well as working clinicians, health sector managers, and supply chain leaders. Policymakers looking to create a more resilient healthcare supply chain in the wake of COVID-19 will also find valuable insight inside.

Author : Sandra L Furterer,Douglas C Wood
Publisher : Quality Press
Page : 555 pages
File Size : 47,8 Mb
Release : 2021-01-25
Category : Business & Economics
ISBN : 9781951058074

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The ASQ Certified Manager of Quality/Organizational Excellence Handbook by Sandra L Furterer,Douglas C Wood Pdf

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.

Author : David N. Burt,Sheila Petcavage,Richard Pinkerton
Publisher : McGraw Hill Professional
Page : 770 pages
File Size : 53,6 Mb
Release : 2012
Category : Business & Economics
ISBN : 9780071770613

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Proactive Purchasing in the Supply Chain: The Key to World-Class Procurement by David N. Burt,Sheila Petcavage,Richard Pinkerton Pdf

Resource added for the Business Management program 101023.

Author : Tugrul U. Daim,Dirk Meissner
Publisher : Springer Nature
Page : 322 pages
File Size : 49,7 Mb
Release : 2020-12-17
Category : Business & Economics
ISBN : 9783030583019

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Innovation Management in the Intelligent World by Tugrul U. Daim,Dirk Meissner Pdf

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.

Author : Susan Neadle
Publisher : CRC Press
Page : 439 pages
File Size : 48,6 Mb
Release : 2023-05-16
Category : Medical
ISBN : 9781000874587

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The Combination Products Handbook by Susan Neadle Pdf

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.

Author : Andrew Cox
Publisher : Financial Times/Prentice Hall
Page : 120 pages
File Size : 52,7 Mb
Release : 2003
Category : Business & Economics
ISBN : 0273662708

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Supply Chain Management by Andrew Cox Pdf

In the last ten years, a revolution has occurred in the way in which companies manage their business strategy and its operational delivery. Called Supply Chain Management (SCM), it is a strategic business model that has been developed in response to increasing global competitive pressures. Many companies have already chosen to outsource all "non-essential" activities (transforming them from fixed to variable costs), to re-focus on their core competencies. And while this type of outsourcing plays well with investors in the short-term, the solution that it offers is only a temporary one - unless it is accompanied by a robust SCM strategy. This is because much of the value offered by companies to their customers is generated externally by the company's suppliers. So, if the company is unable to manage or develop its suppliers or if the suppliers fail to perform, the company's performance is affected too. Evidence suggests that for those firms who are prepared to develop SCM strategies, the payback in terms of competitive advantage and cost reduction can be considerable. In recent years, companies as diverse as IBM, Wal-Mart, Toyota and Dell have all undergone nothing short of a supply chain revolution and today, all regard supply chain management as an essential part of their overall business strategy. This briefing offers a practical working guide to help you and your organisation implement a robust and effective supply chain management approach. Extensive case study material illustrates what should - and should not - be done so that strategic and operational targets can be achieved. This briefing discusses the six key steps in effective SCM: Focus on core competencies Outsource all non-core competencies Align demand and supply: consolidate all similar activities into category management Rationalise the supply base and create strategic alliances with key suppliers Develop long-term supply chain relationships and optimise through e-business technology Undertake proactive supplier and supply chain development

Author : Almir Badnjević,Mario Cifrek,Ratko Magjarević,Zijad Džemić
Publisher : Springer Nature
Page : 441 pages
File Size : 49,6 Mb
Release : 2023-12-28
Category : Technology & Engineering
ISBN : 9783031434440

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Inspection of Medical Devices by Almir Badnjević,Mario Cifrek,Ratko Magjarević,Zijad Džemić Pdf

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!

Author : World Health Organization
Publisher : World Health Organization
Page : 147 pages
File Size : 40,5 Mb
Release : 2010
Category : Medical
ISBN : 9789241564045

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Medical Devices by World Health Organization Pdf

Background papers 1 to 9 published as technical documents. Available in separate records from WHO/HSS/EHT/DIM/10.1 to WHO/HSS/EHT/DIM/10.9