Risk Based Quality And Safety Management In Clinical Trials With Combination Products In Global Regulatory Environment

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Risk-Based Quality and Safety Management in Clinical Trials with Combination Products in Global Regulatory Environment

Author : Marina Malikova
Publisher :
ISBN 13 :
Total Pages : pages
Book Rating : 4.:/5 (116 download)

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Book Synopsis Risk-Based Quality and Safety Management in Clinical Trials with Combination Products in Global Regulatory Environment by : Marina Malikova

Download or read book Risk-Based Quality and Safety Management in Clinical Trials with Combination Products in Global Regulatory Environment written by Marina Malikova and published by . This book was released on 2017 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: Background:Newly emerging products which combine drugs, devices, and biologics are expected to provide new opportuni- ties in bridging device and drug capabilities and establish synergies while bringing sophisticated combination products to consumers. The emergence of these novel products has triggered new regulatory, strategic, and technological challenges. While progress has been made at clarifying the issues that arise most frequently, regulatory authorities and product developers continue to struggle with complex regulatory and technical issues encompassing the development programs for combina- tion products. A risk-based approach requires not only a strategy but also tools to define key indicators to measure specific risks. Key risk indicators (KRIs) and risk-based quality management systems should focus on safety of research subjects and data integrity.Methods:We analyzed current regulatory guidelines throughout the life cycle of combination products and compared old and new approaches to risk-based quality and compliance management for current good manufacturing practices and during pre-clinical and clinical phases of combination products development. Causeu2013effect analysis for two major risk categories in clinical trials with combination products was performed.Results:The results of our analysis are based on observations from 15 clinical trials, which were conducted with combination products. Based on our findings, we proposed practical recommendations for the development of KRIs to improve conduct and ensure safety of research subjects in trials with combination products by utilizing risk-based quality management approach. Conclusion:Combination products, due to their specific nature, can increase risks while being tested in clinical trials. Metrics critical to risks and quality management should be linked to particular processes within development program for combination products. Ongoing collaboration between regulators, industry, and other stakeholders is essential to streamlining of the global combination entities development and approval process in a way that will produce safe and effective products for consumers.

Development and Approval of Combination Products

Author : Evan B. Siegel
Publisher : John Wiley & Sons
ISBN 13 : 0470371196
Total Pages : 233 pages
Book Rating : 4.4/5 (73 download)

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Book Synopsis Development and Approval of Combination Products by : Evan B. Siegel

Download or read book Development and Approval of Combination Products written by Evan B. Siegel and published by John Wiley & Sons. This book was released on 2008-06-09 with total page 233 pages. Available in PDF, EPUB and Kindle. Book excerpt: A step-by-step, integrated approach for successful, FDA-approved combination drug products Using a proven integrated approach to combination drug development, this book guides you step by step through all the preclinical, clinical, and manufacturing stages. Written from an FDA regulatory perspective, the book not only enables you to bring a successful combination drug product to market, it also sets forth the most efficient and effective path to FDA approval. The book begins with an introductory chapter presenting definitions and basic regulatory principles of combination products. Next, it reviews manufacturing and controls, preclinical testing models, pharmacology, clinical testing, regulatory submissions, FDA reviews, and approvals. Among the key topics examined are: * The pharmacology, safety pharmacology, and toxicology supporting human clinical trials of combination products * Approaches to clinical trial protocol design and execution * Chemical, physicochemical, and analytical aspects of manufacturing controls and validation that lead to stable components for combination products * Key sponsor/FDA meetings and negotiations essential for approval and commercialization Case studies involving such actual combination products as Mylotarg, Herceptin, and HercepTest help you better understand how to implement the author's practical guidelines. References at the end of each chapter enable you to find more information on any stage of the development, manufacturing and approval processes. This book is ideal for researchers, regulators, academics, project managers, and executives involved in the complex process of combination product development. Not only does itoffer a comprehensive guide to the technical aspects of the field, it also integrates all ofthese technical aspects into a unified, effective approach to help ensure a successful, approved product.

Combination Products

Author : Smita Gopalaswamy
Publisher : CRC Press
ISBN 13 : 1040068960
Total Pages : 168 pages
Book Rating : 4.0/5 (4 download)

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Book Synopsis Combination Products by : Smita Gopalaswamy

Download or read book Combination Products written by Smita Gopalaswamy and published by CRC Press. This book was released on 2008-04-22 with total page 168 pages. Available in PDF, EPUB and Kindle. Book excerpt: The field of combination product development (products born of the integration of medical devices, biologics, and drugs) is so new that, while literature abounds on each part individually, there are very few publications, including FDA documents, available concerning the unique challenges posed by this nascent but fast-growing area. Providing

Managing the Risks from Medical Product Use

Author : United States. Food and Drug Administration. Task Force on Risk Management
Publisher :
ISBN 13 :
Total Pages : 172 pages
Book Rating : 4.:/5 (319 download)

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Book Synopsis Managing the Risks from Medical Product Use by : United States. Food and Drug Administration. Task Force on Risk Management

Download or read book Managing the Risks from Medical Product Use written by United States. Food and Drug Administration. Task Force on Risk Management and published by . This book was released on 1999 with total page 172 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Quality Risk Management in the FDA-Regulated Industry

Author : José Rodríguez-Pérez
Publisher : Quality Press
ISBN 13 : 1953079326
Total Pages : 252 pages
Book Rating : 4.9/5 (53 download)

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Book Synopsis Quality Risk Management in the FDA-Regulated Industry by : José Rodríguez-Pérez

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.

Design, Execution, and Management of Medical Device Clinical Trials

Author : Salah M. Abdel-aleem
Publisher : John Wiley & Sons
ISBN 13 : 9780470475904
Total Pages : 296 pages
Book Rating : 4.4/5 (759 download)

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Book Synopsis Design, Execution, and Management of Medical Device Clinical Trials by : Salah M. Abdel-aleem

Download or read book Design, Execution, and Management of Medical Device Clinical Trials written by Salah M. Abdel-aleem and published by John Wiley & Sons. This book was released on 2009-08-19 with total page 296 pages. Available in PDF, EPUB and Kindle. Book excerpt: An essential introduction to conducting the various stages of medical device clinical trials Clinical research continues to be one of the most vital components of pharmaceutical, biostatistical, and medical studies. Design, Execution, and Management of Medical Device Clinical Trials provides a uniform methodology for conducting and managing clinical trials. Written in a style that is accessible to readers from diverse educational and professional backgrounds, this book provides an in-depth and broad overview for successfully performing clinical tasks and activities. Throughout the book, practical examples compiled from both the author's and other researchers' previous clinical trial experiences are discussed in a sequential manner as they occur in the study, starting from the development of the clinical protocol and the selection of clinical sites and ending with the completion of the final clinical study report. Next, readers are guided through the development of important clinical documents, including informed consent forms, case report forms, and study logs. A careful review of the Food and Drug Administration (FDA) and International Conference on Harmonisation (ICH) regulations applicable to medical devices is also featured. Additional coverage includes: Qualification and selection of investigators Study monitoring visits Definitions and reporting procedures for adverse events The use of biostatistical methodology in clinical research, including the use of biostatistics for sample size determination and study endpoints The roles and responsibilities of all members of a clinical research team The book concludes with an insightful discussion of special ethical conduct for human research and challenging issues to consider during the design of clinical studies. A glossary lists important clinical and statistical terms used in clinical research, and an extensive reference section provides additional resources for the most up-to-date literature on the topic. Design, Execution, and Management of Medical Device Clinical Trials is an excellent book for clinical research or epidemiology courses at the upper-undergraduate and graduate levels. It is also an indispensable reference for clinical research associates, clinical managers, clinical scientists, biostatisticians, pharmacologists, and any professional working in the field of clinical research who would like to better understand clinical research practices.

Safety Evaluation of Pharmaceuticals and Medical Devices

Author : Shayne C. Gad
Publisher : Springer Science & Business Media
ISBN 13 : 1441974490
Total Pages : 135 pages
Book Rating : 4.4/5 (419 download)

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Book Synopsis Safety Evaluation of Pharmaceuticals and Medical Devices by : Shayne C. Gad

Download or read book Safety Evaluation of Pharmaceuticals and Medical Devices written by Shayne C. Gad and published by Springer Science & Business Media. This book was released on 2010-10-26 with total page 135 pages. Available in PDF, EPUB and Kindle. Book excerpt: The inspiration for this text was the 1988 volume by Alder and Zbinden, written before the ICH harmonization process for drug safety evaluation (or its ISO analog for device biocompatibility evaluation) had been initiated or come to force. Since then, much has changed in both the world and practice of medicine and the regulation of drugs. The intent of this volume is to provide similar guidance as to what nonclinical safety assessment tests need to be performed to move a drug into man, through development and to market approved (this intent was subsequently extended to cover the closely related medical device biotechnology, and combination product fields) in a concise, abbreviated manner for all the major world market countries.

The Combination Products Handbook

Author : Susan Neadle
Publisher : CRC Press
ISBN 13 : 1000874583
Total Pages : 439 pages
Book Rating : 4.0/5 (8 download)

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Book Synopsis The Combination Products Handbook by : Susan Neadle

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.

Public Health Effectiveness of the FDA 510(k) Clearance Process

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309162904
Total Pages : 141 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Public Health Effectiveness of the FDA 510(k) Clearance Process by : Institute of Medicine

Download or read book Public Health Effectiveness of the FDA 510(k) Clearance Process written by Institute of Medicine and published by National Academies Press. This book was released on 2010-10-04 with total page 141 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop.

Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing

Author : Hamid Mollah
Publisher : John Wiley & Sons
ISBN 13 : 0470552344
Total Pages : 432 pages
Book Rating : 4.4/5 (75 download)

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Book Synopsis Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing by : Hamid Mollah

Download or read book Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing written by Hamid Mollah and published by John Wiley & Sons. This book was released on 2013-03-18 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: Sets forth tested and proven risk management practices in drug manufacturing Risk management is essential for safe and efficient pharmaceutical and biopharmaceutical manufacturing, control, and distribution. With this book as their guide, readers involved in all facets of drug manufacturing have a single, expertly written, and organized resource to guide them through all facets of risk management and analysis. It sets forth a solid foundation in risk management concepts and then explains how these concepts are applied to drug manufacturing. Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing features contributions from leading international experts in risk management and drug manufacturing. These contributions reflect the latest research, practices, and industry standards as well as the authors' firsthand experience. Readers can turn to the book for: Basic foundation of risk management principles, practices, and applications Tested and proven tools and methods for managing risk in pharmaceutical and biopharmaceutical product manufacturing processes Recent FDA guidelines, EU regulations, and international standards governing the application of risk management to drug manufacturing Case studies and detailed examples demonstrating the use and results of applying risk management principles to drug product manufacturing Bibliography and extensive references leading to the literature and helpful resources in the field With its unique focus on the application of risk management to biopharmaceutical and pharmaceutical manufacturing, this book is an essential resource for pharmaceutical and process engineers as well as safety and compliance professionals involved in drug manufacturing.

Quality Risk Management in the FDA-Regulated Industry

Author : Jose (Pepe) Rodriguez-Perez
Publisher : Quality Press
ISBN 13 : 1636941575
Total Pages : 293 pages
Book Rating : 4.6/5 (369 download)

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Book Synopsis Quality Risk Management in the FDA-Regulated Industry by : Jose (Pepe) Rodriguez-Perez

Download or read book Quality Risk Management in the FDA-Regulated Industry written by Jose (Pepe) Rodriguez-Perez and published by Quality Press. This book was released on 2024-04-18 with total page 293 pages. Available in PDF, EPUB and Kindle. Book excerpt: For quality professionals and manufacturers in the food safety and medical device industries, risk management is essential to ensuring organizations meet FDA regulations and requirements. Without these recognized standards, the lives of patients and consumers are placed in jeopardy. In this third edition of Quality Risk Management in the FDA-Regulated Industry, Jose Rodriguez-Perez provides an updated view of the risk management field as it applies to FDA-regulated products using risk-based thinking.

Project Management of Clinical Trials

Author : Richard Chamberlain
Publisher : Xlibris Corporation
ISBN 13 : 1796041599
Total Pages : 101 pages
Book Rating : 4.7/5 (96 download)

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Book Synopsis Project Management of Clinical Trials by : Richard Chamberlain

Download or read book Project Management of Clinical Trials written by Richard Chamberlain and published by Xlibris Corporation. This book was released on 2019-09-24 with total page 101 pages. Available in PDF, EPUB and Kindle. Book excerpt: Project Management of Clinical Trials describes how to apply project management principles to conduct clinical research studies. It describes the major deliverables from clinical research and then covers estimating dates, resources, and costs to produce those deliverables. Along with the book is a set of Excel spreadsheets that can be used to estimate the dates and costs to do different types of clinical trials.

The Design and Management of Medical Device Clinical Trials

Author : Salah M. Abdel-aleem
Publisher : John Wiley & Sons
ISBN 13 : 1118164628
Total Pages : 269 pages
Book Rating : 4.1/5 (181 download)

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Book Synopsis The Design and Management of Medical Device Clinical Trials by : Salah M. Abdel-aleem

Download or read book The Design and Management of Medical Device Clinical Trials written by Salah M. Abdel-aleem and published by John Wiley & Sons. This book was released on 2011-09-09 with total page 269 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical trials tasks and activities are widely diverse and require certain skill sets to both plan and execute. This book provides professionals in the field of clinical research with valuable information on the challenging issues of the design, execution, and management of clinical trials, and how to resolve these issues effectively. It discusses key obstacles such as challenges to patient recruitment, investigator and study site selection, and dealing with compliance issues. Through practical examples, professionals working with medical device clinical trials will discover the appropriate steps to take.

Global Clinical Trials Playbook

Author : Menghis Bairu
Publisher : Academic Press
ISBN 13 : 0124157874
Total Pages : 332 pages
Book Rating : 4.1/5 (241 download)

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Book Synopsis Global Clinical Trials Playbook by : Menghis Bairu

Download or read book Global Clinical Trials Playbook written by Menghis Bairu and published by Academic Press. This book was released on 2012-04-20 with total page 332 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceuticals companies, biotech companies, and CROs, regardless of size, all face the same challenge of managing costs and operational execution associated with bringing a valuable drugs and devices to market. Because of timeline pressures and cost as well as the growing interest in "neglected diseases" and diseases affecting the emerging nations, clinical trials are increasingly conducted in emerging markets and developing countries where infrastructure, leadership, skilled personnel and a governance are at a premium. Working with academics, regulatory professionals, safety officers, experts from the pharma industry and CROs, the editors have put together this up-to-date, step-by-step guide book to building and enhancing global clinical trial capacity in emerging markets and developing countries. This book covers the design, conduct, and tools to build and/or enhance human capacity to execute such trials, appealing to individuals in health ministries, pharmaceutical companies, world health organizations, academia, industry, and non-governmental organizations (NGOs) who are managing global clinical trials. Gives medical professionals the business tools needed to effectively execute clinical trials throughout the world Provides real world international examples which illustrate the practical translation of principles Includes forms, templates, and additional references for standardization in a number of global scenarios

Global Clinical Trials

Author : Richard Chin
Publisher : Academic Press
ISBN 13 : 012381538X
Total Pages : 537 pages
Book Rating : 4.1/5 (238 download)

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Book Synopsis Global Clinical Trials by : Richard Chin

Download or read book Global Clinical Trials written by Richard Chin and published by Academic Press. This book was released on 2011-05-06 with total page 537 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book will explore the great opportunities and challenges which exist in conducting clinical trials in developing countries. By exploring the various regulations specific to the major players and providing insight into the logistical challenges including language barriers, this book provides a working tool for clinical researchers and administrators to navigate the intricacies of clinical trials in developing countries. Important topics such as ethical issues will be handled very carefully to highlight the significant differences of conducting this work in various jurisdictions. Overall, it will present a clear and comprehensive guide to the ins-and-outs of clinical trials in various countries to assist in design, development, and effectiveness of these trials. - Contributors include high-profile, respected figures who have paved the way for clinical trials in developing countries - Provides hands-on tools for regulatory and legal requirements and qualification, design, management, and reporting - Case studies outline successes, failures, lessons learned and prospects for future collaboration - Includes country-specific guidelines for the most utilized countries - Foreword by David Feigel, former Head of CDRH at FDA

Translational Medicine

Author : Joy A. Cavagnaro
Publisher : CRC Press
ISBN 13 : 1000471829
Total Pages : 542 pages
Book Rating : 4.0/5 (4 download)

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Book Synopsis Translational Medicine by : Joy A. Cavagnaro

Download or read book Translational Medicine written by Joy A. Cavagnaro and published by CRC Press. This book was released on 2021-11-26 with total page 542 pages. Available in PDF, EPUB and Kindle. Book excerpt: Translational Medicine: Optimizing Preclinical Safety Evaluation of Biopharmaceuticals provides scientists responsible for the translation of novel biopharmaceuticals into clinical trials with a better understanding of how to navigate the obstacles that keep innovative medical research discoveries from becoming new therapies or even making it to clinical trials. The book includes sections on protein-based therapeutics, modified proteins, oligonucleotide-based therapies, monoclonal antibodies, antibody–drug conjugates, gene and cell-based therapies, gene-modified cell-based therapies, combination products, and therapeutic vaccines. Best practices are defined for efficient discovery research to facilitate a science-based, efficient, and predictive preclinical development program to ensure clinical efficacy and safety. Key Features: Defines best practices for leveraging of discovery research to facilitate a development program Includes general principles, animal models, biomarkers, preclinical toxicology testing paradigms, and practical applications Discusses rare diseases Discusses "What-Why-When-How" highlighting different considerations based upon product attributes. Includes special considerations for rare diseases About the Editors Joy A. Cavagnaro is an internationally recognized expert in preclinical development and regulatory strategy with an emphasis on genetic medicines.. Her 40-year career spans academia, government (FDA), and the CRO and biotech industries. She was awarded the 2019 Arnold J Lehman Award from the Society of Toxicology for introducing the concept of science-based, case-by-case approach to preclinical safety evaluation, which became the foundation of ICH S6. She currently serves on scientific advisory boards for advocacy groups and companies and consults and lectures in the area of preclinical development of novel therapies. Mary Ellen Cosenza is a regulatory toxicology consultant with over 30 years of senior leadership experience in the biopharmaceutical industry in the U.S., Europe, and emerging markets. She has held leadership position in both the American College of Toxicology (ACT) and the International Union of Toxicology (IUTOX) and is also an adjunct assistant professor at the University of Southern California where she teaches graduate-level courses in toxicology and regulation of biologics.

Excellence Beyond Compliance

Author : William I. White
Publisher : Taylor & Francis
ISBN 13 : 1351032569
Total Pages : 222 pages
Book Rating : 4.3/5 (51 download)

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Book Synopsis Excellence Beyond Compliance by : William I. White

Download or read book Excellence Beyond Compliance written by William I. White and published by Taylor & Francis. This book was released on 2018-05-16 with total page 222 pages. Available in PDF, EPUB and Kindle. Book excerpt: Many companies limp along from day-to-day treating the quality side of the business as a necessary evil, and doing only what is minimally necessary for compliance to regulations. This kind of approach to compliance almost always results in inefficiencies and sometimes can result in a curious kind of noncompliance. Documentation created with compliance as the sole consideration often ends up confusing the employees who must use the documentation. This book looks beyond what is necessary for compliance alone to address what makes a quality management system (QMS) both effective and efficient. This book also never forgets that real people must make any QMS work; the book provides a blueprint for creating a QMS that real people will find useful. After a review of the challenges that any medical device company faces in the world of today—the multiple sources of QMS requirements—the book poses a question: are we satisfied with the QMS we have now, or could we do better? If we want to do better, this book can help. This book offers: Advice that will lead to an effective and efficient QMS. Detailed guidance on the key decisions to be made regarding the quality system being established. Detailed ideas on how to execute those decisions. Up-to-date information on compliance to current regulations and standards and guidance on staying up to date. Specific examples of procedures. Information regarding requirements for combination products, such as a drug + device combination. Advice on incorporating risk management in the QMS.