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Author :
Publisher : Quality First International
ISBN 13 : 1903757002
Total Pages : 179 pages
Book Rating : 4.9/5 (37 download)
Download or read book Biological Safety & European Medical Device Regulations written by and published by Quality First International. This book was released on with total page 179 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : G.R Higson
Publisher : CRC Press
ISBN 13 : 1420033980
Total Pages : 278 pages
Book Rating : 4.4/5 (2 download)
Download or read book Medical Device Safety written by G.R Higson and published by CRC Press. This book was released on 2001-10-29 with total page 278 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical Device Safety: The Regulation of Medical Devices for Public Health and Safety examines the prospects for achieving global harmonization in medical device regulation and describes a possible future global system. Unresolved difficulties are discussed while solutions are proposed. An essential book for all those involved in health physics, en
Author : Prakash Srinivasan Timiri Shanmugam
Publisher : Springer Nature
ISBN 13 : 3030918556
Total Pages : 382 pages
Book Rating : 4.0/5 (39 download)
Download or read book Medical Device Guidelines and Regulations Handbook written by Prakash Srinivasan Timiri Shanmugam and published by Springer Nature. This book was released on 2022-04-22 with total page 382 pages. Available in PDF, EPUB and Kindle. Book excerpt: This comprehensive resource features in-depth discussions of important guidelines and regulations needed to understand and properly meet medical device code-related requirements. Focusing on the practical application of the regulations, the Medical Device Guidelines and Regulations Handbook delivers clear explanations, real-world examples, and annotation on the applicable provisions that will allow you to safely and confidently choose materials and processes for medical device development, testing, and manufacturing. A critical resource for researchers and professionals in the medical device field; Thoroughly covers ISO 10993, ISO 22442, ISO 14971, ISO 13485, ISO 21534, REACH, RoHS, CLP, EU MDR; Presents simplified guidelines and regulation points.
Author : Michael Cheng
Publisher : World Health Organization
ISBN 13 : 9241546182
Total Pages : 54 pages
Book Rating : 4.2/5 (415 download)
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.
Author : Ann-Marie Jahn
Publisher : GRIN Verlag
ISBN 13 : 3668123217
Total Pages : 80 pages
Book Rating : 4.6/5 (681 download)
Download or read book A Comparative Analysis of Medical Device Regulations in the EU and the USA written by Ann-Marie Jahn and published by GRIN Verlag. This book was released on 2016-01-12 with total page 80 pages. Available in PDF, EPUB and Kindle. Book excerpt: Bachelor Thesis from the year 2012 in the subject Economy - Health Economics, grade: First, Berlin School of Economics and Law, language: English, abstract: Innovations in the medical device industry have improved the health of the world population with the ability to better diagnose, prevent, predict and cure illnesses. The number of medical devices on the market is increasing exponentially, together with the complexity, diversity and technical variation of such products. In light of its impact on patient health, regulation of medical devices is necessary to ensure that safe and effective products enter the marketplace, and that the product’s benefit to the patient population outweighs its potential risks. Although there has been increasing public scrutiny of health care reform, medical devices and their global regulation has been a minor field of health economic studies. This study examines the medical device regulatory systems and its impact on health care economics, exemplarily on the legislative programs of two major markets - the United States (U.S.) and European Union (EU). Modern medical device technology dates its origin to the early 19th century, but has grown most significantly in the last 50 years (Banta, p. 15). Today, 10,000 different families of medical device types exist with more than 400,000 different individual products on the market (Eucomed 2011). Outstanding developments have included heart-lung machines, artificial joints, as well as radiographic imaging and the means to perform advanced brain surgery. The medical device technology sector is extremely innovative, with seven out of ten major medical innovations in the last 40 years coming from this field (Fuchs, Sox, JR. 2001). Despite these technological advances, medical devices sometimes fail during use and can actually result in patient harm. The purpose of regulating medical equipment is to minimize the risk of harm to the end user and to prevent potentially unsafe products from entering the marketplace. The main obstacle in developing and implementing effective regulation is the term safety itself, as it can hardly be measured and there is no formula that can be consistently applied. Guidelines have been established that measure product risk, mitigate risks where possible, and then evaluate the residual risks to determine which are acceptable. This means by implication that acceptance of risk is part of the regulation process in order to bring life-saving technologies with unknown long-term effects to the market.
Author :
Publisher : Global Regulatory Press
ISBN 13 : 1903757037
Total Pages : 9 pages
Book Rating : 4.9/5 (37 download)
Download or read book Medical Device Regulations in Europe (Countries N to Z) written by and published by Global Regulatory Press. This book was released on with total page 9 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Christa Altenstetter
Publisher : Routledge
ISBN 13 : 1351506285
Total Pages : 277 pages
Book Rating : 4.3/5 (515 download)
Download or read book Medical Devices written by Christa Altenstetter and published by Routledge. This book was released on 2017-09-08 with total page 277 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical devices are the bread and butter from which health care and clinical research are derived. Such devices are used for patient care, genetic testing, clinical trials, and experimental clinical investigations. Without medical devices, there is no clinical research or patient care. Without life-adjusting devices, there are no medical procedures or surgery. Without life-saving and life-maintaining devices, there is no improvement in well-being and quality of life. Without innovative medical devices and experimentation, there can be no medical progress or patient safety. Medical devices and medical technology are used to create or support many different products and medical-surgical procedures. This volume on the regulation of medical devices in the European Union, with a focus on France, tackles a topic of interdisciplinary interest and significance for policymakers in countries around the globe. The EU regulatory regime is one of three global regional regimes, and medical products manufactured in EU countries are sold worldwide. As countries confront an aging population on a global scale, with associated increases in chronic diseases, physical handicaps, and multi-morbidity, there will inevitably be an increase in the demand for health services and, concomitantly, the use of medical devices in medical and surgical procedures. This will be the case regardless of whether services are delivered in hospitals, doctors' offices, or at home. The associated risks of a particular device will be the same whatever the country of origin for the device, or where the need occurs. Revolutionary medical advances increase diagnostic capabilities, but they increase the potential of harm and risks to patients. Medical technologies and devices are used ethically most of the time; yet they have the potential for unethical use when scientific medicine is elevated over human life and death. Assumptions that are taken for granted can be dangerous to a patient's health. That is why our understanding of appropriate and effective regulation of medical devices is significant to all people on all continents.
Author : John J. Tobin
Publisher : John Wiley & Sons
ISBN 13 : 3527644717
Total Pages : 304 pages
Book Rating : 4.5/5 (276 download)
Download or read book Medical Product Regulatory Affairs written by John J. Tobin and published by John Wiley & Sons. This book was released on 2011-08-24 with total page 304 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written in a clear and concise style by an experienced author, this attractively-priced book covers regulatory affairs in all major global markets for pharmaceuticals and medical devices, making it the most comprehensive in its field. Following a look at drug development, complete sections are devoted to national and EU regulatory issues, manufacturing license application and retention, and regulation in the USA. Other topics dealt with include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/Manufacturing Practices. Everything pharmacologists, bioengineers, pharma engineers, students in pharmacy and those working in the pharmaceutical industry need to know about medical regulatory affairs.
Author : Des O'Brien
Publisher :
ISBN 13 : 9781092813518
Total Pages : 127 pages
Book Rating : 4.8/5 (135 download)
Download or read book European Medical Device Regulation (MDR) for MedTech and Medical Device Manufacturers written by Des O'Brien and published by . This book was released on 2019-04-05 with total page 127 pages. Available in PDF, EPUB and Kindle. Book excerpt: The new European regulations on medical devices and in vitro medical devices were adopted on 05 April 2017 and came into force on 25th May 2017. Both these 2 new regulations replace and repeal Council Directives 90/385/EEC, 93/42/EEC Directive 98/79/EC and Commission Decision 2010/227/EU. This short book (approx 120 pages) provides a foundation overview of the new regulations and how they are structured. It must be stated that many notified bodies and companies provide insight and guidance online, this book provides a tangible resource for day to day use or for gaining an introduction to EU MDR, or alternatively as an ongoing quick reference guide. Although adopted and in force, the new rules shall only apply after a 3-year transitional period, whereby regulations will enter into force in April 2020 for medical devices and for five years after entry into force (April 2022) for the Regulation on in-vitro diagnostic medical devices.
Author : Jean-Pierre Boutrand
Publisher : Woodhead Publishing
ISBN 13 : 0081026447
Total Pages : 592 pages
Book Rating : 4.0/5 (81 download)
Download or read book Biocompatibility and Performance of Medical Devices written by Jean-Pierre Boutrand and published by Woodhead Publishing. This book was released on 2019-11-21 with total page 592 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biocompatibility and Performance of Medical Devices, Second Edition, provides an understanding of the biocompatibility and performance tests for ensuring that biomaterials and medical devices are safe and will perform as expected in the biological environment. Sections cover key concepts and challenges faced in relation to biocompatibility in medical devices, discuss the evaluation and characterization of biocompatibility in medical devices, describe preclinical performance studies for bone, dental and soft tissue implants, and provide information on the regulation of medical devices in the European Union, Japan and China. The book concludes with a review of histopathology principles for biocompatibility and performance studies. - Presents diverse insights from experts in government, industry and academia - Delivers a comprehensive overview of testing and interpreting medical device performance - Expanded to include new information, including sections on managing extractables, accelerating and simplifying medical device development through screening and alternative biocompatibility methods, and quality strategies which fasten device access to market
Author : U. S. Government Accountability Office (
Publisher : BiblioGov
ISBN 13 : 9781289026547
Total Pages : 56 pages
Book Rating : 4.0/5 (265 download)
Download or read book Medical Device Regulation written by U. S. Government Accountability Office ( and published by BiblioGov. This book was released on 2013-06 with total page 56 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pursuant to a congressional request, GAO compared the Food and Drug Administration's (FDA) and the European Union's (EU) systems for reviewing and approving medical devices, focusing on: (1) key differences between the two systems; (2) the outputs of the two systems; and (3) the feasibility of FDA adopting features of the EU system. GAO found that: (1) U.S. and EU medical device regulatory systems share the goal of protecting public health, but the EU system is designed to facilitate EU-wide trade; (2) while EU reviews medical devices for safety and performance, FDA reviews devices for safety, effectiveness, and benefit to patients; (3) while EU gives major medical device regulatory responsibilities to public agencies and private organizations, FDA has sole responsibility over device regulation in the United States; (4) both systems link the level of medical review to device risk, but the two systems use different procedures to reach approval or clearance decisions; (5) questions and concerns have arisen regarding possible conflicts-of-interest in the EU medical device review process because EU notified bodies carry out a regulatory function within the EU medical device system and conflict-of-interest rules for EU reviewers are less comprehensive than in the United States; (6) sufficient data does not exist on the EU medical device review system to permit meaningful comparison with FDA because the EU system is new and not yet fully operational; and (7) it is too early to evaluate the impact of new FDA streamlined review procedures.
Author : Dirk Lanzerath
Publisher :
ISBN 13 : 3643962606
Total Pages : 168 pages
Book Rating : 4.6/5 (439 download)
Download or read book The Development of Medical Devices written by Dirk Lanzerath and published by . This book was released on 2020 with total page 168 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : United States. General Accounting Office
Publisher :
ISBN 13 :
Total Pages : 52 pages
Book Rating : 4.3/5 (91 download)
Download or read book Medical Device Regulation written by United States. General Accounting Office and published by . This book was released on 1996 with total page 52 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Jack Wong
Publisher : CRC Press
ISBN 13 : 0429996764
Total Pages : 475 pages
Book Rating : 4.4/5 (299 download)
Download or read book Handbook of Medical Device Regulatory Affairs in Asia written by Jack Wong and published by CRC Press. This book was released on 2018-03-28 with total page 475 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical device regulation in Asia has gained more importance than ever. Governments and regulatory bodies across the region have put in place new regulatory systems or refined the existing ones. A registered product requires a lot of technical documentation to prove its efficacy, safety, and quality. A smooth and successful registration process demands soft skills for dealing with various key stakeholders in the government, testing centers, and hospitals and among doctors. 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. Each chapter provides substantial background materials relevant to the particular area to have a better understanding of regulatory affairs.
Author : Wolfgang Ecker
Publisher : BoD – Books on Demand
ISBN 13 : 3756278964
Total Pages : 346 pages
Book Rating : 4.7/5 (562 download)
Download or read book Medical Devices and IVDs written by Wolfgang Ecker and published by BoD – Books on Demand. This book was released on 2022-04-25 with total page 346 pages. Available in PDF, EPUB and Kindle. Book excerpt: With this book, you get a really complete seminar for the new Regulations on medical devices and IVDs in the EU, ready at hand, at any time. These EU regulations create new rules for medical technology and laboratory diagnostics in Europe. Concise regulatory know-how is now required to keep or reposition medical devices and in vitro diagnostics on the European market, from syringes, contact lenses, medical device apps, pregnancy tests, nuclear magnetic resonance tomography to cancer tests, genetic diagnostics, HIV tests, hip implants, heart catheters, artificial spinal discs, stents and pacemakers. Concise regulatory training and further education of employees in companies and health care facilities is the order of the day. This also applies to biomedical and medical technology students at universities of applied sciences and biomedical universities, start-ups and spin-offs, who must make use of this know-how from the initial product idea through the further stages of product development to market access. The book provides a thorough, compact course on the new regulations, starting with perfect overview and easy navigation and going into depth where you need it: this book will make you fit and confident for the new European challenges! 344 pages; 47 col. figures; 26 tables
Author : Sharon Frank
Publisher : Europa Law Pub Netherlands
ISBN 13 : 9789089520524
Total Pages : 313 pages
Book Rating : 4.5/5 (25 download)
Download or read book A New Model for European Medical Device Regulation written by Sharon Frank and published by Europa Law Pub Netherlands. This book was released on 2003-10 with total page 313 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book analyses the regulation of medical devices at the federal level in the United States and in the European Union. It covers fundamental aspects (substantive and procedural) of the regulation of medical devices in both regimes, in order to assess the current European institutional framework. The author proposes regulatory reforms for the regulation of medical devices. It is suggested to create a new Community body, the European Medical Device Agency. The US Food and Drug Administration has served as a source of inspiration. This book gives answers to the question why a European Medical Device Agency is needed, its legal implications and its competences and structure (including how to organise all relevant parties concerned). It is proposed that the European Medical Device Agency should have a central role in the regulation of medical devices throughout the European Union. About the author: Sharon Frank (1972, Utrecht, the Netherlands) studied law at the Free University of Amsterdam, the University of Amsterdam, the Hebrew University in Jerusalem and Saint Louis University School of Law (US). From 1999-2002 she was a Ph.D candidate at the E.M.Meijers Institute for Legal Studies at Leyden University. In the frameworkof her Ph.D research, she visited the European University Institutein Florence in 2001. In 2000-2002 she was affiliated with the University of Amsterdam, lecturing European law at the Europa Institute and the Tulane-Amsterdam Summer School. Since 2003 she has been working at the Dutch Ministry of Justice.
Download or read book Medical Device Safety Service written by and published by . This book was released on 1998 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: Documents, news items, etc. concerning the European Union's regulation of medical devices. The MDSS can serve as the European representative for companies manufacturing medical devices.
