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Author: James B. Shore
Publisher: Quality Press
ISBN: 1953079660
Category : Business & Economics
Languages : en
Pages : 132
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Book Description
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: James B. Shore
Publisher: Quality Press
ISBN: 0873899318
Category : Business & Economics
Languages : en
Pages : 108
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Book Description
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.
Author: Justin Cardisco
Publisher:
ISBN:
Category :
Languages : en
Pages : 0
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Book Description
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.
Author: Dev Raheja
Publisher: CRC Press
ISBN: 1466568224
Category : Business & Economics
Languages : en
Pages : 234
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Book Description
A critical and often overlooked aspect of preventing medical device recalls is the ability to implement systems thinking. Although systems thinking won’t prevent every mistake, it remains one of the most effective tools for evaluating hidden risks and discovering robust solutions for eliminating those risks. Based on the author’s extensive experience in the medical device, aerospace, and manufacturing engineering industries, Preventing Medical Device Recalls presents a detailed structure for systems thinking that can help to prevent costly device recalls. Based on Dr. W. Edwards Deming’s System of Profound Knowledge, this structure can help medical device designers and manufacturers exceed their customers’ expectations for quality and safety. This book is among the first to demonstrate how to control safety risks—from specifications all the way through to safely retiring products without harm to the environment. Supplying an accessible overview of medical device requirements and the science of safety, it explains why risk analysis must start with product specification and continue throughout the product life cycle. Covering paradigms for proactive thinking and doing, the text details methods that readers can implement during the specification writing, product design, and product development phases to prevent recalls. It also includes numerous examples from the author’s experience in the medical device, consumer, and aerospace industries. Even in healthcare, where compliance with standards is at its highest level, more patients die from medical mistakes each week than would be involved in a jumbo jet crash. With coverage that includes risk assessment and risk management, this book provides you with an understanding of how mishaps happen so you can account for unexpected events and design devices that are free of costly recalls.
Author: Hedley Rees
Publisher: John Wiley & Sons
ISBN: 0470922842
Category : Medical
Languages : en
Pages : 458
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Book Description
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.
Author: Dr. Akash Sharma, Ms. Vriti Gamta, Mr.Gaurav Luthra
Publisher: Notion Press
ISBN:
Category : Medical
Languages : en
Pages : 105
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Book Description
"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.
Author: World Health Organization
Publisher: Who Medical Device Technical
ISBN: 9789241501378
Category : Medical
Languages : en
Pages : 0
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Book Description
WHO and partners have been working towards devising an agenda, an action plan, tools and guidelines to increase access to appropriate medical devices. This document is part of a series of reference documents being developed for use at the country level. The series will include the following subject areas: . policy framework for health technology . medical device regulations . health technology assessment . health technology management . needs assessment of medical devices . medical device procurement . medical equipment donations . medical equipment inventory management . medical equipment maintenance . computerized maintenance management systems . medical device data . medical device nomenclature . medical devices by health-care setting . medical devices by clinical procedures . medical device innovation, research and development. These documents are intended for use by biomedical engineers, health managers, donors, nongovernmental organizations and academic institutions involved in health technology at the district, national, regional or global levels. Poor practices in the arena of procurement lead to substandard provision or performance of health technology. This document summarizes currently available resources on how to achieve good practice in procurement. The focus is on medical devices; however, the principles and processes outlined can also be applied to the procurement of infrastructure facilities and other supplies.
Author: Susanne Manz
Publisher: Academic Press
ISBN: 9780128142219
Category : Science
Languages : en
Pages : 0
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Book Description
Medical Devices Quality Management Systems: Strategy and Techniques for Improving Efficiency and Effectiveness is written for the needs of quality, compliance, and regulatory professionals in medical device companies. It includes secrets for developing an effective, yet efficient, Quality Management System (QMS) and explains how to create a vision, strategy, and tactical plans. Author Manz shares lessons on leadership, key roles and responsibilities within a medical device company, while also exploring the concepts of process ownership, individual accountability, and how to cultivate a culture of quality and compliance. This book is useful for all executive, functional leaders, and organizations in the highly regulated medical device industry.
Author: Peter J. Ogrodnik
Publisher: Academic Press
ISBN: 9780123919427
Category : Medical
Languages : en
Pages : 350
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Book Description
This book provides the bridge between engineering design and medical device development. There is no single text that addresses the plethora of design issues a medical devices designer meets when developing new products or improving older ones. It addresses medical devices' regulatory (FDA and EU) requirements--some of the most stringent engineering requirements globally. Engineers failing to meet these requirements can cause serious harm to users as well as their products' commercial prospects. This Handbook shows the essential methodologies medical designers must understand to ensure their products meet requirements. It brings together proven design protocols and puts them in an explicit medical context based on the author's years of academia (R&D phase) and industrial (commercialization phase) experience. This design methodology enables engineers and medical device manufacturers to bring new products to the marketplace rapidly. The medical device market is a multi-billion dollar industry. Every engineered product for this sector, from scalpelsstents to complex medical equipment, must be designed and developed to approved procedures and standards. This book shows how. Covers US, and EU and ISO standards, enabling a truly international approach, providing a guide to the international standards that practicing engineers require to understand. Written by an experienced medical device engineers and entrepreneurs with products in the from the US and UK and with real world experience of developing and commercializing medical products.
Author: Melissa M. Medina
Publisher:
ISBN:
Category :
Languages : en
Pages : 29
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Book Description
Changing regulatory requirements continues to be an increasingly complex issue in the medical device industry. Regulations place stress on regional supply chains across the world. Most recently, the European Parliament issued the Medical Device Regulation (EU) 2017/745 instituting new compliance framework for all devices manufactured, sold, and/or distributed in the European Union. The new framework requires the implementation of unique device identifiers and more stringent conformity assessment procedures. In addition, many device classification types have changed, post-market clinical surveillance has been instituted, and traceability through a centralized IT database is now mandated. While the the act aims to improve patient safety and efficacy across the medical device industry, it poses huge impacts across both the physical and informational flows in supply chains. This research evaluates the regulatory impact across supply chain operations using predictive modeling and machine learning. The model determines how various activities and events in manufacturing and sourcing environments contribute to supply constraints when modified to accommodate new regulatory requirements. The model also determines how product attributes contribute to performance variability. By taking a proactive approach to assess the impacts of regulatory changes, firms can optimize supply chain flows to reduce cost, lead-time, and service level risks.
Author: Mark Allen Durivage
Publisher: Quality Press
ISBN: 1636941214
Category : Business & Economics
Languages : en
Pages : 323
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Book Description
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.
