Market introduction of innovative high risk medical devices / Imgard Vinck in European Journal of Health Law, 18(2011)05 ([12/01/2011]) 

[article] Market introduction of innovative high risk medical devices : towards a recast of the directive concerning medical devices. [printed text] / Imgard Vinck, Author ; Frank Hulstaert, Author ; Hans Van Brabandt, Author ; Mattias Neyt, Author ; Sabine Stordeur, Author . - 2011 . - 477-89. Languages : English (eng) inEuropean Journal of Health Law > 18(2011)05 [12/01/2011] . - 477-89 Descriptors: Classification W 1 Serials. Periodicals Indexation Controlled Clinical Trials ; Device Approval ; Europe ; Government Regulation ; Humans ; Journal Article ; Liability, Legal ; Peer Review ; United States Abstract: The European Conformity (CE) marking grants early market introduction to innovative high risk medical devices based on safety and device performance only, without any requirement to demonstrate clinical efficacy or effectiveness. Hence healthcare providers, patients and payers are informed neither about the added clinical value compared to an existing medical device nor about the risks incurred by using such innovations. In addition there is a lack of coherence and uniformity of approach in the assessment of high risk medical devices. These gaps may put the health and safety of patients in danger. The European Commission, in concert with Competent Authorities, industry, Notified Bodies, and other stakeholders, is working on a "recast" of the directives regulating medical devices. This article identifies and discusses the critical points of the pre-market clinical evaluation of innovative high-risk medical devices in the European legal framework and compares it with the USA. Link for e-copy: http://www.brill.nl/european-journal-health-law Format of e-copy: PDF [Requires Subscription] Record link: http://kce.docressources.info/opac/index.php?lvl=notice_display&id=2934 [article]

European Journal of Health Law / Martinus Nijhoff Publishers - 1994  

[serial]  See available issues European Journal of Health Law = Eur J Health Law [printed text] . - Netherlands : Martinus Nijhoff Publishers, 1994. ISSN : 1571-8093 IF : none mentioned SJR : http://www.scimagojr.com/journalsearch.php?q=13220&tip=sid&clean=0 Indexed : Medline (1994-2000 ; 2003-....) Languages : English (eng) Descriptors: Classification W 1 Serials. Periodicals Indexation Delivery of Health Care ; Europe ; Legislation, Medical ; Peer Review ; Periodicals Abstract: The European Journal of Health Law focuses on the development of health law in Europe: national, comparative and international. The exchange of views between health lawyers in Europe is encouraged. The Journal publishes information on the activities of European and other international organizations in the field of health law. Discussions about ethical questions with legal implications are welcome. National legislation, court decisions and other relevant national material with international implications are also dealt with. Each issue of the European Journal of Health Law contains articles (with abstracts), selected legislation, judicial decisions, a chronicle of events, and book reviews. Link for e-copy: http://www.brill.nl/european-journal-health-law Format of e-copy: PDF [Requires Subscription] Record link: http://kce.docressources.info/opac/index.php?lvl=notice_display&id=2933 [serial]  See available issues

The Healthy Life Years (HLY) indicator / JA:EHLEIS - 2010  

The Healthy Life Years (HLY) indicator [electronic document] . - [S.l.] : JA:EHLEIS, 2010. Languages : English (eng) French (fre) Descriptors: Classification W 26.55.I4 Information systems. Information storage and retrieval Indexation Aged ; Databases, Factual ; Europe ; Quality of Life ; statistics and numerical data [Subheading] Abstract: The proposed new EU structural indicator Healthy Life Years (HLY) is a disability-free life expectancy, one of the most common health expectancies reported. It is based on limitations in daily activities and therefore measures the number of remaining years that a person of a particular age can expect to live without disability. Health expectancies were first developed to address whether or not longer life is being accompanied by an increase in the time lived in good or in bad health. So health expectancies divide life expectancy into life spent in different states of health. In this way they add a dimension of quality to the quantity of life lived. There are as many health expectancies as dimensions of health. Link for e-copy: http://www.healthy-life-years.eu/index.php?c=hly&l=en&s=hly Format of e-copy: Online [Free] Record link: http://kce.docressources.info/opac/index.php?lvl=notice_display&id=2932

EBM Guidelines / EBMPracticeNET - 2011  

EBM Guidelines [electronic document] . - [S.l.] : EBMPracticeNET, 2011. Languages : English (eng) Descriptors: Classification W 84 Health services. Quality of health care (General) Indexation Belgium ; Practice Guideline, Publishers' catalogue Abstract: Evidence-Based Medicine Guidelines collects, summarizes, and updates the core clinical knowledge essential in general practice and ambulatory care. The guidelines also describe the scientific evidence underlying the given recommendations. Link for e-copy: http://www.ebmpracticenet.be/eng/Pages/default.aspx Format of e-copy: Online [FREE] Record link: http://kce.docressources.info/opac/index.php?lvl=notice_display&id=2931

Social Determinants of Health / Juha Mikkonen / Toronto [Canada] : The Canadian Facts - 2010  

Social Determinants of Health : The Canadian Facts [printed text] / Juha Mikkonen, Author ; Denis Raphael, Author . - Toronto (62 First Avenue, M4M 1W8, Canada) : The Canadian Facts, 2010 . - 62 p. : ill. ; A4. ISBN : 978-0-968348-41-3 : € 0,00 Languages : English (eng) Descriptors: Indexation Canada ; Health Policy ; Public Health ; Social aspects ; Social policy Classification WA 100 Public Health -- General works Contents note: 1. Introduction 5 -- 2. Stress, Bodies, and Illness 6 -- 3. Income and Income Distribution 15 -- 4. Education 17 -- 5. Unemployment and Job Security 18 -- 6. Employment and Working Conditions 21 -- 7. Early Childhood Development 24 -- 8. Food Insecurity 27 -- 9. Housing 29 -- 10. Social Exclusion 32 -- 11. Social Safety Net 34 -- 12. Health Services 37 -- 13. Aboriginal Status 39 -- 14. Gender 43 -- 15. Race 47 -- 16. Disability 49 -- 17. What You Can Do 53 -- Appendix I. Resources and Supports 59 -- Appendix II. Quotation Sources 61 Link for e-copy: http://www.thecanadianfacts.org/The_Canadian_Facts.pdf Format of e-copy: PDF [Open Access](4,31 Mb) Record link: http://kce.docressources.info/opac/index.php?lvl=notice_display&id=2928

Niet Vanzelfsprekend / Helga Van Loo / Leuven [Belgium] : ACCO - 2003

Niet Vanzelfsprekend : Een vervolgmethode Nederlands voor anderstaligen Leerboek [printed text] / Helga Van Loo, Author ; Peter Schoenaerts, Author ; Han Fraeters, Author . - Leuven (Belgium) : ACCO, 2003 . - 384 p. : ill. ; 22 cm. ISBN : 978-90-334-5429-5 : € 45 Languages : Dutch (nla) Descriptors: Classification L - EDUCATION Indexation education ; Handbooks ; Teaching Materials Record link: http://kce.docressources.info/opac/index.php?lvl=notice_display&id=2926

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Medical Device and Diagnostic Industry / Heather Thompson / Los Angeles [United States] : UBM Canon - 2012  

[serial] Medical Device and Diagnostic Industry = MD+DI [printed text] / Heather Thompson, Publishing director . - Los Angeles (11444 W. Olympic Blvd, CA90064, United States) : UBM Canon, 2012. Languages : English (eng) Descriptors: Classification W 1 Serials. Periodicals Indexation Equipment and Supplies ; United States Abstract: Medical Device + Diagnostic Industry is a magazine written exclusively for original equipment manufacturers of medical devices and in vitro diagnostic products. The goal of MD+DI is to help industry professionals develop, design, and manufacture medical products that comply with complex and demanding regulations and market requirements. MD+DI delivers editorial content that readers can find nowhere else. Whether they're looking for information to help their buying decisions, to improve their manufacturing and design processes, to comply with regulations, or to understand market demand, they know they will find it in MD+DI. Link for e-copy: http://www.mddionline.com/ Format of e-copy: Webpage Record link: http://kce.docressources.info/opac/index.php?lvl=notice_display&id=2925 [serial]

ASM Medical Materials Database / OHIO [United States] : ASM International - 2011  

ASM Medical Materials Database [electronic document] . - OHIO (9639 Kinsman Rd, 44073-0001, United States) : ASM International, 2011. Languages : English (eng) Descriptors: Classification W 26.55.I4 Information systems. Information storage and retrieval Indexation Databases, Medical Devices ; Disabled Persons ; Equipment and Supplies Abstract: It's the first and only comprehensive, peer-reviewed database that provides a single source for materials data to support medical device design. This fully relational and modular catalog features both materials properties and biological response data for medical device designers. Quickly screen, analyze, select, and source candidate materials and coatings for device applications and compatible drugs. Save time, gain insight into the design process, lower development costs, and get to market faster. Get a competitive advantage with the ASM Medical Materials Database Link for e-copy: http://products.asminternational.org/meddev/index.aspx Format of e-copy: Webpage Record link: http://kce.docressources.info/opac/index.php?lvl=notice_display&id=2924

Medical Device Databases / U.S. Food and Drug Administration (FDA) - 2011  

Medical Device Databases [electronic document] . - USA : U.S. Food and Drug Administration (FDA), 2011. Languages : English (eng) Descriptors: Indexation Databases, Medical Devices ; United States Classification WX 147 Equipment and supplies Link for e-copy: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Databases/default. [...] Format of e-copy: Webpage Record link: http://kce.docressources.info/opac/index.php?lvl=notice_display&id=2923

AbleData / Silver Spring [United States] : AbleData 

AbleData : Products [electronic document] . - Silver Spring (8630 Fenton Street, Suite 930, MD 20910, United States) : AbleData, [s.d.]. Languages : English (eng) Descriptors: Classification W 26.55.I4 Information systems. Information storage and retrieval Indexation Databases, Medical Devices ; Disabled Persons ; Equipment and Supplies Abstract: We classify the products listed in the AbleData database of assistive technology by each product's intended function or any special features it possesses. The products are classified in 20 areas listed below. Clicking on a topic will link you to a list of the major categories within that topic, from which you can see the list of specific product types in that category. Just point and click. Link for e-copy: http://www.abledata.com/abledata.cfm?pageid=19327&ksectionid=19327 Format of e-copy: Webpage Record link: http://kce.docressources.info/opac/index.php?lvl=notice_display&id=2922