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| Author | : United States. Bureau of Medical Devices and Diagnostic Products |
| Publisher | : |
| Total Pages | : 24 |
| Release | : 1976 |
| Genre | : Medical instruments and apparatus |
| ISBN | : |
| Author | : |
| Publisher | : |
| Total Pages | : |
| Release | : 1976* |
| Genre | : Medical instruments and apparatus |
| ISBN | : |
| Author | : Christian Baumgartner |
| Publisher | : Springer Nature |
| Total Pages | : 671 |
| Release | : 2023-08-26 |
| Genre | : Technology & Engineering |
| ISBN | : 3031220919 |
This updatable reference work gives a comprehensive overview of all relevant regulatory information and requirements for manufacturers and distributors around medical and in-vitro diagnostic devices in Europe. These individual requirements are presented in a practice-oriented manner, providing the reader with a concrete guide to implementation with main focus on the EU medical device regulations, such as MDR 2017/745 and IVD-R 2017/746, and the relevant standards, such as the ISO 13485, ISO 14971, among others. This book offers a good balance of expert knowledge, empirical values and practice-proven methods. Not only it provides readers with a quick overview about the most important requirements in the medical device sector, yet it shows concrete and proven ways in which these requirements can be implemented in practice. It addresses medical manufacturing companies, professionals in development, production, and quality assurance departments, and technical and medical students who are preparing themselves for a professional career in the medical technlogy industries.
| Author | : Institute of Medicine |
| Publisher | : National Academies Press |
| Total Pages | : 141 |
| Release | : 2010-10-04 |
| Genre | : Medical |
| ISBN | : 0309162904 |
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.
| Author | : Charles Sidebottom |
| Publisher | : CRC Press |
| Total Pages | : 616 |
| Release | : 2019-08-30 |
| Genre | : |
| ISBN | : 9780367395162 |
Completely revised, this second edition provides the practical, hands-on labeling information needed to secure rapid regulatory approval, gain marketplace acceptance, and assure user comprehension. A complete guide to all aspects of advertising, labeling, and packaging, it explains the relevant laws, regulations, and requirements in major markets worldwide and provides examples of compliance and noncompliance. Coverage includes requirements such as text, dimensions, type sizes, graphic elements, symbols, and language for implantable devices, sterile devices, over the counter products, in vitro diagnostic products, radiation emitting devices, contraceptive devices, and more.
| Author | : |
| Publisher | : |
| Total Pages | : 48 |
| Release | : 1990 |
| Genre | : Diagnosis, Laboratory |
| ISBN | : |
| Author | : Elijah Wreh |
| Publisher | : Elsevier |
| Total Pages | : 680 |
| Release | : 2023-02-22 |
| Genre | : Technology & Engineering |
| ISBN | : 0323953530 |
Medical Device Regulation provides the current FDA-CDRH thinking on the regulation of medical devices. This book offers information on how devices meet criteria for being a medical device, which agencies regulate medical devices, how policies regarding regulation affect the market, rules regarding marketing, and laws and standards that govern testing. This practical, well-structured reference tool helps medical device manufacturers both in and out of the United States with premarket application and meeting complex FDA regulatory requirements. The book delivers a comprehensive overview of the field from an author with expertise in regulatory affairs and commercialization of medical devices. Offers a unique focus on the regulatory affairs industry, specifically targeted at regulatory affairs professionals and those seeking certification Puts regulations in the context of contemporary design Includes case studies and applications of regulations
| Author | : Jack Wong |
| Publisher | : CRC Press |
| Total Pages | : 620 |
| Release | : 2022-01-27 |
| Genre | : Medical |
| ISBN | : 1000440532 |
This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Experts from influential international regulatory bodies, including the US Food and Drug Administration (FDA), UK Medicines and Healthcare Products Regulatory Agency, Japan Pharmaceuticals and Medical Devices Agency, Saudi Food and Drug Authority, Korea Testing Laboratory, Taiwan FDA, World Health Organization, Asian Harmonization Working Party, Regulatory Affairs Professionals Society, and British Standards Institution, have contributed to the book. Government bodies, the medical device industry, academics, students, and general readers will find the book immensely useful for understanding the global regulatory environment and in their research and development projects.
| Author | : Norman F. Estrin |
| Publisher | : CRC Press |
| Total Pages | : 1020 |
| Release | : 1990-08-31 |
| Genre | : Medical |
| ISBN | : 9780824782689 |
Practical information about the complexities of biomedical technology and regulation, and their implications for manufacturers and marketers of health care devices. Written primarily for those in the industry concerned about staying competitive in light of complex and fluctuating regulatory approach
| Author | : Susanne Manz |
| Publisher | : Academic Press |
| Total Pages | : 298 |
| Release | : 2018-09-27 |
| Genre | : Science |
| ISBN | : 0128142227 |
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. Provides practical, real-world guidance on developing an effective and efficient Quality Management System Presents a roadmap for QMS development Covers techniques to assess current state Includes discussions on tools, such as CAPA and Six Sigma that help define vision, strategy and quality plans
