Download or read book Directory of Medical Device Standards and Reference Documents written by Canada. Health Protection Branch and published by . This book was released on 1991 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Medical Devices Guideline written by Canadian Government Publishing and published by . This book was released on 1991 with total page 143 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Directory of Medical Device Standards and Reference Documents written by and published by . This book was released on 1991 with total page 156 pages. Available in PDF, EPUB and Kindle. Book excerpt: With 1991: contains domestic, foreign, and international standards for medical devices. Intended for those involved in standards development or interested in specifying safety and performance.

Download or read book Directory of Medical Device Standards and Reference Documents written by Canadian Hospital Association and published by . This book was released on 1991 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Directory of Medical Device Standards and Reference Documents 1991 written by Canada. Bureau of Radiation and Medical Devices. Standards and Testing Section and published by . This book was released on 1991 with total page 139 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Directory of medical device standards and reference documents 1991 written by Canada. Bureau de la radioprotection et des instruments médicaux. Section des normes et des essais and published by Canadian Hospital Association Press = Presses de l'Association des hôpitaux du Canada. This book was released on 1991 with total page 139 pages. Available in PDF, EPUB and Kindle. Book excerpt:

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 Medical Technology Assessment Directory written by Institute of Medicine and published by National Academies Press. This book was released on 1988-02-01 with total page 709 pages. Available in PDF, EPUB and Kindle. Book excerpt: For 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.

Download or read book The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices written by Amiram Daniel and published by Quality Press. This book was released on 2008-01-01 with total page 355 pages. Available in PDF, EPUB and Kindle. Book excerpt: How 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.

Download or read book Medical Device Listing written by United States. Bureau of Medical Devices and published by . This book was released on 1978 with total page 48 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Medical Devices Measurements Quality Assurance and Standards written by Cesar Augusto Caceres and published by ASTM International. This book was released on 1983 with total page 319 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Bureau of Medical Devices Standards Survey written by and published by . This book was released on 1979 with total page 316 pages. Available in PDF, EPUB and Kindle. Book excerpt:

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 620 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.

Download or read book Bureau of Medical Devices Standards Survey written by United States. Bureau of Medical Devices and published by . This book was released on 1977 with total page 240 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Global atlas of medical devices 2022 written by World Health Organization and published by World Health Organization. This book was released on 2022-11-24 with total page 608 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Handbook of Medical Device Design written by Richard C. Fries and published by CRC Press. This book was released on 2000-09-14 with total page 795 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Handbook of Medical Device Design provides a review of regulatory and standards issues in medical device design, including FDA regulations, types of 510 (k), the ISO 9000 series, and medical device directives. It identifies how to determine and document customer needs and device requirements. It also establishes reliability and qua

Download or read book Catalogue of the Public Documents of the Congress and of All Departments of the Government of the United States for the Period from to written by United States. Superintendent of Documents and published by . This book was released on with total page 2556 pages. Available in PDF, EPUB and Kindle. Book excerpt: