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Author:
Publisher: Washington Business Information
ISBN: 9781932074109
Category : Medical instruments and apparatus
Languages : en
Pages : 356
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Book Description
Author:
Publisher: Washington Business Information
ISBN: 9781932074109
Category : Medical instruments and apparatus
Languages : en
Pages : 356
Get Book Here
Book Description
Author: Food and Drug Administration
Publisher:
ISBN: 9780865879737
Category : Drugs
Languages : en
Pages : 0
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Book Description
Available now to FDA-regulated organizations, this manual allows facility managers to look at their operation's regulatory compliance through the eyes of the government. Because this is the primary reference manual used by FDA personnel to conduct field investigation activities, you can feel confident you are preparing appropriate planning or action. This manual includes revised instructions regarding the release of information and covers FDA's policies and expectations on a comprehensive range of topics: FDA's authority to enter and inspect, inspection notification, detailed inspection procedures, recall monitoring, inspecting import procedures, computerized data requests, federal/state inspection relationships, discussions with management regarding privileged information, seizure and prosecution, HACCP, bioengineered food, dietary supplements, cosmetics, bioterrorism, and product disposition. The manual also includes a directory of Office of Regulatory Affairs offices and divisions.
Author: United States. Food and Drug Administration
Publisher:
ISBN:
Category : Biotechnology
Languages : en
Pages : 62
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Book Description
Author: Michael Hausner
Publisher: SPIE-International Society for Optical Engineering
ISBN: 9781510601796
Category : Optical materials
Languages : en
Pages :
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Book Description
"This book instructs inspectors and designers of optical elements and assemblies with the primary means of inspection and testing, as well as the relevant tools and instruments"--
Author: Scott A Laman
Publisher: Quality Press
ISBN: 1953079970
Category : Medical
Languages : en
Pages : 372
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Book Description
The ASQ Certified Medical Device Auditor Handbook (formerly The Biomedical Quality Auditor Handbook) was developed by the ASQ Medical Device Division (formerly Biomedical Division) in support of its mission to promote the awareness and use of quality principles, concepts, and technologies in the medical device community. It principally serves as a resource to candidates preparing for the Certified Medical Device Auditor (CMDA) certification exam. The fourth edition of this handbook has been reorganized to align with the 2020 certification exam Body of Knowledge (BoK) and reference list. The combination of this handbook with other reference materials can provide a well-rounded background in medical device auditing. Updates to this edition include: • A discussion of data privacy, data integrity principles, and the Medical Device Single Audit Program (MDSAP) • Current information about federal and international regulations • New content regarding human factors and usability engineering, general safety and performance requirements, labeling, validation, risk management, and cybersecurity considerations • A thorough explanation of quality tools and techniques
Author:
Publisher:
ISBN:
Category : Medical instruments and apparatus industry
Languages : en
Pages : 32
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Book Description
Author: Theodore R. Kucklick
Publisher: CRC Press
ISBN: 104007913X
Category : Medical
Languages : en
Pages : 513
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Book Description
Exploring the practical, entrepreneurial, and historical aspects of medical device development, this second edition of The Medical Device R&D Handbook provides a how-to guide for medical device product development. The book offers knowledge of practical skills such as prototyping, plastics selection, and catheter construction, allowing designer
Author: Shayne Cox Gad
Publisher: CRC Press
ISBN: 1482248387
Category : Medical
Languages : en
Pages : 588
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Book Description
Biomaterials, Medical Devices, and Combination Products is a single-volume guide for those responsible for-or concerned with-developing and ensuring patient safety in the use and manufacture of medical devices.The book provides a clear presentation of the global regulatory requirements and challenges in evaluating the biocompatibility and clinical
Author: Gerald E. McDonnell
Publisher: John Wiley & Sons
ISBN: 1444330136
Category : Medical
Languages : en
Pages : 466
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Book Description
Prevention is the first line of defence in the fight against infection. As antibiotics and other antimicrobials encounter increasing reports of microbial resistance, the field of decontamination science is undergoing a major revival. A Practical Guide to Decontamination in Healthcare is a comprehensive training manual, providing practical guidance on all aspects of decontamination including: microbiology and infection control; regulations and standards; containment, transportation, handling, cleaning, disinfection and sterilization of patient used devices; surgical instrumentation; endoscopes; and quality management systems. Written by highly experienced professionals, A Practical Guide to Decontaminationin Healthcare comprises a systematic review of decontamination methods, with uses and advantages outlined for each. Up-to-date regulations, standards and guidelines are incorporated throughout, to better equip healthcare professionals with the information they need to meet the technical and operational challenges of medical decontamination. A Practical Guide to Decontaminationin Healthcare is an important new volume on state-of-the-art decontamination processes and a key reference source for all healthcare professionals working in infectious diseases, infection control/prevention and decontamination services.
Author: FDAnews
Publisher:
ISBN: 9781932074451
Category : Medical instruments and apparatus
Languages : en
Pages :
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Book Description
