Author: Espicom Business IntelligencePublisher:
ISBN: 9781858222929
Category : Medical instruments and apparatus industry
Languages : en
Pages :
Book Description
Guide to Distributors of Medical Equipment and Supplies Worldwide 2007
Author: Espicom Business IntelligencePublisher:
ISBN: 9781858222929
Category : Medical instruments and apparatus industry
Languages : en
Pages :
Book Description
Medical Devices
Author: World Health OrganizationPublisher: World Health Organization
ISBN: 9241564040
Category : Medical
Languages : en
Pages : 147
Book Description
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
WHO Global Model Regulatory Framework for Medical Devices Including in Vitro Diagnostic Medical Devices
Author: World Health OrganizationPublisher:
ISBN: 9789241512350
Category : Law
Languages : en
Pages : 72
Book Description
The Model recommends guiding principles and harmonized definitions and specifies the attributes of effective and efficient regulation to be embodied within binding and enforceable law. Its main elements refer to international harmonization guidance documents developed by the Global Harmonization Task Force (GHTF) and its successor, the International Medical Device Regulators Forum (IMDRF). The Model is particularly relevant for WHO Member States with little or no regulation for medical devices currently in place but with the ambition to improve this situation. It foresees that such countries will progress from basic regulatory controls towards an expanded level to the extent that their resources allow. The Model is written for the legislative, executive, and regulatory branches of government as they develop and establish a system of medical devices regulation. It describes the role and responsibilities of a country's regulatory authority for implementing and enforcing the regulations. Also, it describes circumstances in which a regulatory authority may either "rely on" or "recognize" the work products from trusted regulatory sources (such as scientific assessments, audit, and inspection reports) or from the WHO Prequalification Team. Section 2 of this document recommends definitions of the terms "medical devices" and IVDs. It describes how they may be grouped according to their potential for harm to the patient or user and specifies principles of safety and performance that the device manufacturer must adhere to. It explains how the manufacturer must demonstrate to a regulatory authority that its medical device has been designed and manufactured to be safe and to perform as intended during its lifetime. Section 3 presents the principles of good regulatory practice and enabling conditions for effectively regulating medical devices. It then introduces essential tools for regulation, explaining the function of the regulatory entity and the resources required. Section 4 presents a stepwise approach to implementing and enforcing regulatory controls for medical devices as the regulation progresses from a basic to an expanded level. It describes elements from which a country may choose according to national priorities and challenges. Also, it provides information on when the techniques of reliance and recognition may be considered and on the importance of international convergence of regulatory practice.Section 5 provides a list of additional topics to be considered when developing and implementing regulations for medical devices. It explains the relevance of these topics and provides guidance for regulatory authorities to ensure that they are addressed appropriately. The Model outlines a general approach but cannot provide country-specific guidance on implementation. While it does not offer detailed guidance on regulatory topics, it contains references to relevant documents where further information may be found. It does not detail the responsibilities of other stakeholders such as manufacturers, distributors, procurement agencies, and health-care professionals, all of whom have roles in assuring the quality, safety, and performance of medical devices.
The Almanac of American Employers: The Only Guide to America's Hottest, Fastest-Growing Major Corporations
Author: Jack W. PlunkettPublisher: Plunkett Research, Ltd.
ISBN: 1593921438
Category : Business & Economics
Languages : en
Pages : 729
Book Description
Market research guide to American employers. Includes hard-to-find information such as benefit plans, stock plans, salaries, hiring and recruiting plans, training and corporate culture, growth plans. Several indexes and tables, as well as a job market trends analysis and 7 Keys For Research for job openings. This massive reference book features our proprietary profiles of the 500 best, largest, and fastest-growing corporate employers in America--includes addresses, phone numbers, and Internet addresses.
Plunkett's Health Care Industry Almanac 2007: Health Care Industry Market Research, Statistics, Trends & Leading Companies
Author: Jack W. PlunbettPublisher: Plunkett Research, Ltd.
ISBN: 1593920792
Category : Business & Economics
Languages : en
Pages : 734
Book Description
Contains information to understand the trends, technologies, finances, and leading companies of a specific industry.
Plunkett's Health Care Industry Almanac
Author: Jack W. PlunkettPublisher: Plunkett Research, Ltd.
ISBN: 1593921322
Category : Medical care
Languages : en
Pages : 734
Book Description
This acclaimed and popular text is the only complete market research guide to the American health care industry--a tool for strategic planning, competitive intelligence, employment searches or financial research. Covers national health expenditures, technologies, patient populations, research, Medicare, Medicaid, managed care. Contains trends, statistical tables and an in-depth glossary. Features in-depth profiles of the 500 major firms in all health industry sectors.
Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation
Author: Orlando LopezPublisher: Taylor & Francis
ISBN: 1351704346
Category : Business & Economics
Languages : en
Pages : 232
Book Description
Validation of computer systems is the process that assures the formal assessment and report of quality and performance measures for all the life-cycle stages of software and system development, its implementation, qualification and acceptance, operation, modification, requalification, maintenance and retirement (PICS CSV PI 011-3). It is a process that demonstrates the compliance of computer systems functional and non-functional requirements, data integrity, regulated company procedures and safety requirements, industry standards, and applicable regulatory authority’s requirements. Compliance is a state of being in adherence to application-related standards or conventions or regulations in laws and similar prescriptions. This book, which is relevant to the pharmaceutical and medical devices regulated operations, provides practical information to assist in the computer validation to production systems, while highlighting and efficiently integrating worldwide regulation into the subject. A practical approach is presented to increase efficiency and to ensure that the validation of computer systems is correctly achieved.
International Medical Guide for Ships
Author: World Health OrganizationPublisher: World Health Organization
ISBN: 9241547200
Category : Medical
Languages : en
Pages : 491
Book Description
This publication shows designated first-aid providers how to diagnose, treat, and prevent the health problems of seafarers on board ship. This edition contains fully updated recommendations aimed to promote and protect the health of seafarers, and is consistent with the latest revisions of both the WHO Model List of Essential Medicines and the International Health Regulations.--Publisher's description.
Import / Export Kit For Dummies
Author: John J. CapelaPublisher: John Wiley & Sons
ISBN: 1119079675
Category : Business & Economics
Languages : en
Pages : 381
Book Description
Your easy-to-follow primer on the exciting world of import/export With an increased focus on global trade, this new edition of Import/Export Kit For Dummies provides entrepreneurs and small- to mid-sized businesses with the critical, entry-point information they need to begin exporting their products around the world—as well as importing goods to sell. Inside, you'll find the most up-to-date information on trade regulations, where to turn for additional guidance on seamlessly navigating the dreaded red tape, and much more. With significant changes in technology, expanding economics, and international trade agreements, the global marketplace continues to grow and change rapidly. In fact, companies that do business internationally are proven to grow faster and fail less often than companies that don't. This authoritative reference is packed with everything you need to get started, so why not get in on the game while the going is good? Gets you up to speed on the lingo of international business Shows you how to follow guidelines for developing a successful business and marketing plan Helps you understand distributor and agent agreement outlines Offers unprecedented insight on pinpointing the right markets for your import/export business Importing and exporting goods is a valuable way to expand your business and take part in the global economy, and this hands-on, friendly guide shows you how.
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