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Author: Publisher: ISBN: Category : Medical instruments and apparatus Languages : en Pages : 1692
Book Description
Contains a list of all manufacturers and other specified processors of medical devices registered with the Food and Drug Administration, and permitted to do business in the U.S., with addresses and telephone numbers. Organized by FDA medical device name, in alphabetical order. Keyword index to FDA established standard names of medical devices.
Author: Publisher: ISBN: Category : Medical instruments and apparatus Languages : en Pages : 1692
Book Description
Contains a list of all manufacturers and other specified processors of medical devices registered with the Food and Drug Administration, and permitted to do business in the U.S., with addresses and telephone numbers. Organized by FDA medical device name, in alphabetical order. Keyword index to FDA established standard names of medical devices.
Author: Center for Devices and Radiological Health (U.S.). Office of Compliance and Surveillance Publisher: ISBN: Category : Medical instruments and apparatus Languages : en Pages : 5
Author: Center for Devices and Radiological Health (U.S.). Office of Compliance and Surveillance Publisher: ISBN: Category : Medical instruments and apparatus Languages : en Pages : 12
Author: Elijah Wreh Publisher: Elsevier ISBN: 0323953530 Category : Technology & Engineering Languages : en Pages : 680
Book Description
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: Aakash Deep Publisher: Academic Press ISBN: 0323911277 Category : Technology & Engineering Languages : en Pages : 187
Book Description
Medical Device Regulations: A Complete Guide describes a brief review of various regulatory bodies of major developed and developing countries around the world. The book covers the registration procedures of medical devices for pharmaceutical regulatory organizations. Sections provide guidance on dealing with the ethical considerations of medical device development, compliance with patient confidentiality using information from medical devices, the interoperability between, and among devices outside of healthcare, and the dynamics of implementation of new devices to ensure patient safety. The author brings forth relevant issues, challenges and demonstrates how management can foster increased clinical and non-clinical relations to enhance patient outcomes and the bottom-line by demystifying the regulatory impact on operational requirements. Provides clear information on regulatory pathways for the design and commercialization of Medical Devices in different countries Explains the difference between standards and mandatory regulations for each region, along with discussions of regulations from USFDA (USA), CDSCO (India), EMEA (European Union), SFDA (China) and PMDA (Japan) Compiles regulations for medical devices and pharmaceuticals worldwide, helping readers create globally compliant products
Author: Laura Mars-Proietti Publisher: ISBN: 9781592373734 Category : Medical instruments and apparatus Languages : en Pages : 0
Book Description
The only one-stop resource of every medical supplier licensed to sell products in the US. This edition offers immediate access to over 13,000 companies-and more than 65,000 products - in two information-packed volumes. This comprehensive resource saves hours of time and trouble when searching for medical equipment and supplies and the manufacturers who provide them. Volume I: The Product Directory, provides essential information for purchasing or specifying medical supplies for every medical device, supply, and diagnostic available in the US. Listings provide FDA codes & Federal Procurement Eligibility, Contact information for every manufacturer of the product along with Prices and Product Specifications. Volume 2: Supplier Profiles, offers the most complete and important data about Suppliers, Manufacturers and Distributors. Company Profiles detail the number of employees, ownership, method of distribution, sales volume, net income, key executives, detailed contact information, the medical products the company supplies, plus the medical specialties they cover. Four indexes provide immediate access to this wealth of information: Keyword Index, Trade Name Index, Supplier Geographical Index and OEM (Original Equipment Manufacturer) Index. Medical Device Register is the only one-stop source for locating suppliers and products; looking for new manufacturers or hard-to-find medical devices; comparing products and companies; knowing who's selling what and who to buy from cost effectively. This directory has become the standard in its field and will be a welcome addition to the reference collection of any medical library, large public library, university library, along with the collections that serve the medical community.
Author: Canon Communications Publisher: ISBN: 9781592374465 Category : Medical instruments and apparatus Languages : en Pages : 0
Book Description
The only one-stop resource of every medical supplier licensed to sell products in the US. This edition offers immediate access to over 13,000 companies-and more than 65,000 products - in two information-packed volumes. This comprehensive resource saves hours of time and trouble when searching for medical equipment and supplies and the manufacturers who provide them. Volume I: The Product Directory, provides essential information for purchasing or specifying medical supplies for every medical device, supply, and diagnostic available in the US. Listings provide FDA codes & Federal Procurement Eligibility, Contact information for every manufacturer of the product along with Prices and Product Specifications. Volume 2: Supplier Profiles, offers the most complete and important data about Suppliers, Manufacturers and Distributors. Company Profiles detail the number of employees, ownership, method of distribution, sales volume, net income, key executives, detailed contact information, the medical products the company supplies, plus the medical specialties they cover. Four indexes provide immediate access to this wealth of information: Keyword Index, Trade Name Index, Supplier Geographical Index and OEM (Original Equipment Manufacturer) Index. Medical Device Register is the only one-stop source for locating suppliers and products; looking for new manufacturers or hard-to-find medical devices; comparing products and companies; knowing who's selling what and who to buy from cost effectively. This directory has become the standard in its field and will be a welcome addition to the reference collection of any medical library, large public library, university library, along with the collections that serve the medical community.
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Author: Center for Devices and Radiological Health (U.S.). Office of Compliance and Surveillance
Author: Center for Devices and Radiological Health (U.S.). Office of Compliance and Surveillance
Author: Medical Economics
Author: Elijah Wreh
Author: Aakash Deep
Author: Laura Mars-Proietti
Author: Mdr
Author: Canon Communications