Directory of Medical Device Standards and Reference Documents
Author: Canada. Health Protection Branch
Publisher:
Published: 1991
Total Pages:
ISBN-13:
DOWNLOAD EBOOKRead and Download eBook Full
Author: Canada. Health Protection Branch
Publisher:
Published: 1991
Total Pages:
ISBN-13:
DOWNLOAD EBOOKAuthor: Canadian Government Publishing
Publisher:
Published: 1991
Total Pages: 143
ISBN-13: 9780660573168
DOWNLOAD EBOOKAuthor:
Publisher:
Published: 1991
Total Pages: 156
ISBN-13:
DOWNLOAD EBOOKWith 1991: contains domestic, foreign, and international standards for medical devices. Intended for those involved in standards development or interested in specifying safety and performance.
Author: Canadian Hospital Association
Publisher:
Published: 1991
Total Pages:
ISBN-13:
DOWNLOAD EBOOKAuthor: Canada. Bureau of Radiation and Medical Devices. Standards and Testing Section
Publisher:
Published: 1991
Total Pages: 139
ISBN-13:
DOWNLOAD EBOOKAuthor: Canada. Bureau de la radioprotection et des instruments médicaux. Section des normes et des essais
Publisher: Canadian Hospital Association Press = Presses de l'Association des hôpitaux du Canada
Published: 1991
Total Pages: 139
ISBN-13:
DOWNLOAD EBOOKAuthor: Michael Cheng
Publisher: World Health Organization
Published: 2003-09-16
Total Pages: 54
ISBN-13: 9241546182
DOWNLOAD EBOOKThe 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: Institute of Medicine
Publisher: National Academies Press
Published: 1988-02-01
Total Pages: 709
ISBN-13: 0309038294
DOWNLOAD EBOOKFor the first time, a single reference identifies medical technology assessment programs. A valuable guide to the field, this directory contains more than 60 profiles of programs that conduct and report on medical technology assessments. Each profile includes a listing of report citations for that program, and all the reports are indexed under major subject headings. Also included is a cross-listing of technology assessment report citations arranged by type of technology headings, brief descriptions of approximately 70 information sources of potential interest to technology assessors, and addresses and descriptions of 70 organizations with memberships, activities, publications, and other functions relevant to the medical technology assessment community.
Author: Amiram Daniel
Publisher: Quality Press
Published: 2008-01-01
Total Pages: 355
ISBN-13: 0873897404
DOWNLOAD EBOOKHow have recent changes in domestic and international regulations affected quality management in the development and marketing of medical devices in the US and abroad? Consultants Daniel and Kimmelman take a close look at the Quality System Regulation (QsReg), the ISO 13485: 2003 standard and the ISO/TR 14969: 2004 guidance document as well as a number of US Food and Drug Administration (FDA) and Global Harmonization Task Force (GHTF) guidance documents. The authors provide extensive commentary and notes an update their material to include such topics as the incorporation of principles of risk management into the medical device organizations' quality management systems (QMSs) and considerations of combination products. Daniel and Kimmelman include full coverage of the QSReg requirements, descriptions of comparable requirements in the ISO documents, excerpts of the FDA's responses to the QSReg preamble and excerpts from FDA guidance documents related to QMSs.
Author: Jack Wong
Publisher: CRC Press
Published: 2022-01-27
Total Pages: 806
ISBN-13: 1000440516
DOWNLOAD EBOOKThis 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. Experts from influential international regulatory bodies, including the US Food and Drug Administration (FDA), UK Medicines and Healthcare Products Regulatory Agency, Japan Pharmaceuticals and Medical Devices Agency, Saudi Food and Drug Authority, Korea Testing Laboratory, Taiwan FDA, World Health Organization, Asian Harmonization Working Party, Regulatory Affairs Professionals Society, and British Standards Institution, have contributed to the book. Government bodies, the medical device industry, academics, students, and general readers will find the book immensely useful for understanding the global regulatory environment and in their research and development projects.