Download or read book Medical Device written by Rommel Garcia and published by Xlibris Corporation. This book was released on 2017-06-06 with total page 403 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is meant to be a guide to all who want to learn about a highly regulated industry. My approach is to give you, the reader, an example of a fictitious device, and we will take it from a conceptual idea all the way to launch and beyond. My intention is to incorporate the best experiences that I and other contributors have had into this book and convert them into laymans terms for those who are in need. These experiences can and will be indispensable to beginners and professionals alike who are trying their hand in the medical device industry and to those who have not been out of their silo to help see how each of the systems relate to each as a whole. However, it should be noted that the contents of this book should be taken only as information and is not intended to demonstrate how companies can be in compliance. In some instances, there are multiple ways to go through the maze of regulations that are documented and made by agencies because the regulations are pretty much made and designed to be flexible and high level so that companies can adopt their systems, which are solely designed for their purposes. Therefore, this book will try to avoid complicated words and complex technical details of engineering and statistics. This book will strive to be an embodiment of the honest-to-goodness, everyday experiences and issues that folks experience while working in the medical device industry.
Download or read book Medical Device Regulations written by Michael Cheng and published by World Health Organization. This book was released on 2003-09-16 with total page 54 pages. Available in PDF, EPUB and Kindle. Book excerpt: The term 'medical devices' covers a wide range of equipment essential for patient care at every level of the health service, whether at the bedside, at a health clinic or in a large specialised hospital. Yet many countries lack access to high-quality devices, particularly in developing countries where health technology assessments are rare and there is a lack of regulatory controls to prevent the use of substandard devices. This publication provides a guidance framework for countries wishing to create or modify their own regulatory systems for medical devices, based on best practice experience in other countries. Issues highlighted include: the need for harmonised regulations; and the adoption, where appropriate, of device approvals of advanced regulatory systems to avoid an unnecessary drain on scarce resources. These approaches allow emphasis to be placed on locally-assessed needs, including vendor and device registration, training and surveillance and information exchange systems.
Download or read book GB Chinese National Standard PDF Translated English Product Catalog National standard GB Series written by https://www.chinesestandard.net and published by https://www.chinesestandard.net. This book was released on 2018-01-01 with total page 552 pages. Available in PDF, EPUB and Kindle. Book excerpt: This document provides the comprehensive list of Chinese National Standards - Category: GB Series.
Download or read book Medical and Care Compunetics 4 written by Lodewijk Bos and published by IOS Press. This book was released on 2007 with total page 332 pages. Available in PDF, EPUB and Kindle. Book excerpt: The role of the International Council on Medical and Care Compunetics (ICMCC) with regards to patient-related ICT has become obvious with the start of the Record Access Portal. This work aims to come forward with a recommendation to the WHO on Record Access.
Download or read book Federal Register written by and published by . This book was released on 2014 with total page 244 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Inspection of Medical Devices written by Almir Badnjević and published by Springer. This book was released on 2017-10-26 with total page 285 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book offers all countries a guide to implementing verification systems for medical devices to ensure they satisfy their regulations. It describes the processes, procedures and need for integrating medical devices into the legal metrology framework, addresses their independent safety and performance verification, and highlights the associated savings for national healthcare systems, all with the ultimate goal of increasing the efficacy and reliability of patient diagnoses and treatment. The book primarily focuses on diagnostic and therapeutic medical devices, and reflects the latest international directives and regulations. Above all, the book demonstrates that integrating medical devices into the legal metrology system and establishing a fully operational national laboratory for the inspection of medical devices could significantly improve the reliability of medical devices in diagnosis and patient care, while also reducing costs for the healthcare system in the respective country.
Download or read book CE MARKING BOOK OF ELECTRICAL AND ELECTRONIC PRODUCTS written by CHETAN KATHALAY and published by CHETAN KATHALAY. This book was released on 2020-06-03 with total page 157 pages. Available in PDF, EPUB and Kindle. Book excerpt: Buy CE marking book in India.This book gives a step-by-step approach to CE marking of electrical and electronic equipment including risk assessment. It covers, in detail, five important directives viz. low voltage directive (LVD), electromagnetic compatibility (EMC) directive, medical devices directive (MDD), radio equipment directive (RED) and the RoHS directive. It provides insights into product design and test methodologies especially EMC and product SAFETY so that the product meets the technical requirements of the applicable standards. It also seeks to clarify the many doubts and misconceptions about CE marking. The book begins with a chapter that introduces the reader to the nuances of the CE marking process, the conformity assessment modules and to compile supporting documents that illustrate the process. This is followed by the chapter on product safety which describes the principles of safety as found in the international IEC and European harmonized safety standards. It provides ways and means to improve product design so as to ensure reasonable compliance when a product is subject to safety evaluation by a test laboratory. Then, there are two chapters dedicated to EMC. One explains the EMC fundamentals, standards and the test methodology while the other deals with EMC design. The design chapter contains ways and means to incorporate EMC measures like line filters, shielding, grounding and cable routing at the design stage so that the product can comply with the EMC tests with a minimum of iterations. The design means discussed are very practical in nature and are given in such a way that the design engineer can immediately incorporate them without worrying too much about theory. All the directives now-a-days require a detailed risk assessment to be carried out in addition to testing as per standards. Thereafter the risk assessment needs to be documented so as to demonstrate how the risks have been reduced/eliminated. The book deals with the risk assessment in detail for all the directives under consideration. And last but not the least, the CE marking procedure is not complete unless the entire process is documented through the so-called technical file or technical documentation. The last chapter explains the compilation of technical documentation as required by the directives and the European surveillance authorities.
Download or read book YB YB T YBT Product Catalog Translated English of Chinese Standard YB YB T YBT written by https://www.chinesestandard.net and published by https://www.chinesestandard.net. This book was released on 2018-01-01 with total page 88 pages. Available in PDF, EPUB and Kindle. Book excerpt: This document provides the comprehensive list of Chinese Industry Standards - Category: YB; YB/T; YBT.
Download or read book Bureau of Medical Devices Standards Survey written by and published by . This book was released on 1982 with total page 412 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Introduction to Biomedical Engineering Technology written by Laurence J. Street and published by CRC Press. This book was released on 2016-09-19 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: This new edition provides major revisions to a text that is suitable for the introduction to biomedical engineering technology course offered in a number of technical institutes and colleges in Canada and the US. Each chapter has been thoroughly updated with new photos and illustrations which depict the most modern equipment available in medical technology. This third edition includes new problem sets and examples, detailed block diagrams and schematics and new chapters on device technologies and information technology.
Download or read book Reliable Design of Medical Devices written by Richard C. Fries and published by CRC Press. This book was released on 1997-01-30 with total page 734 pages. Available in PDF, EPUB and Kindle. Book excerpt: Presenting the basic concepts and major issues associated with medical device design, this text describes current development processes as well as standards and regulatory information, providing a basis for assessing new technologies. It aims to help manufacturers establish and operate a viable reliability assurance programme, and purchasers to formulate effective methods of vendor evaluation.
Download or read book Handbook of Laboratory Health and Safety Measures written by S.B. Pal and published by Springer Science & Business Media. This book was released on 2013-03-14 with total page 577 pages. Available in PDF, EPUB and Kindle. Book excerpt: During the past two decades, many books, governmental reports and regu lations on safety measures against chemieals, fire, microbiological and radioactive hazards in laboratories have been published from various coun tries. These topics have also been briefly discussed in books on laboratory planning and management. The application ofvarious scientific instruments based on different ionizing and non-ionizing radiations have brought new safety problems to the laboratory workers of today, irrespective of their scientific disciplines, be they medicine, natural or life sciences. However, no comprehensive laboratory handbook dealing with aIl these hazards, some of which are recently introduced, had so far been available in a single volume. Therefore, it was thought worthwhile to publish this Handbook on safety and health measures for laboratories, with contributions from several experts on these subjects. As this second edition of the Handbook, like the first edition, is a multiauthor volume, some duplication in conte nt among chapters is unavoidable in order to maintain the context of a chapter as weIl as make each chapter complete. An attempt has also been made to maintain the central theme, which is how to work in a laboratory with maximum possible environmental safety.
Download or read book Electromagnetic Fields in Biological Systems written by James C. Lin and published by CRC Press. This book was released on 2016-04-19 with total page 460 pages. Available in PDF, EPUB and Kindle. Book excerpt: Spanning static fields to terahertz waves, this volume explores the range of consequences electromagnetic fields have on the human body. Topics discussed include essential interactions and field coupling phenomena; electric field interactions in cells, focusing on ultrashort, pulsed high-intensity fields; dosimetry or coupling of ELF fields into biological systems; and the historical developments and recent trends in numerical dosimetry. It also discusses mobile communication devices and the dosimetry of RF radiation into the human body, exposure and dosimetry associated with MRI and spectroscopy, and available data on the interaction of terahertz radiation with biological tissues, cells, organelles, and molecules.
Download or read book Computer Safety Reliability and Security written by Andrea Bondavalli and published by Springer. This book was released on 2014-09-03 with total page 356 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book constitutes the refereed proceedings of the 33nd International Conference on Computer Safety, Reliability, and Security, SAFECOMP 2014, held in Florence, Italy, in September 2014. The 20 revised full papers presented together with 3 practical experience reports were carefully reviewed and selected from 85 submissions. The papers are organized in topical sections on fault injection techniques, verification and validation techniques, automotive systems, coverage models and mitigation techniques, assurance cases and arguments, system analysis, security and trust, notations/languages for safety related aspects, safety and security.
Download or read book GB T 2020 GB 2020 Chinese National Standard PDF English Catalog year 2020 written by https://www.chinesestandard.net and published by https://www.chinesestandard.net. This book was released on 2020-06-06 with total page 220 pages. Available in PDF, EPUB and Kindle. Book excerpt: This document provides the comprehensive list of Chinese National Standards - Category: GB, GB/T Series of year 2020.
Download or read book WHO technical guidance and specifications of medical devices for screening and treatment of precancerous lesions in the prevention of cervical cancer written by World Health Organization and published by World Health Organization. This book was released on 2020-05-11 with total page 220 pages. Available in PDF, EPUB and Kindle. Book excerpt:
