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... Evaluation of clinical data Standard Quality management system SS-EN ISO 13485:2012 Standard Risk management SS-EN ISO 14971:2009 Standard Biological evaluation SS-EN ISO ... standards Quality management system SS-EN ISO 13485:2003 Risk management SS-EN ISO 14971:2007 Biological ...

http://www.hu.liu.se/larc/good-clinical-practice/kursmaterial/1.418159/MedicaldevicesiclinicaltrialsLiULinkping20121120rev1Handsout..ppt

Date added: March 9, 2013 - Views: 33

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Guidelines - AIDS 2012

Inspection of the QMS at production site (ISO 13485/GMP) ... Where a reference standard or method is not available, a method comparison study can be submitted. ... ISO 23640:2011. In vitro diagnostic medical devices ...

http://pag.aids2012.org/PAGMaterial/PPT/259_406/12%2007%2025_gv%202_tips%20for%20pqdx_aids%20conf.pptx

Date added: August 18, 2013 - Views: 24

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スライド 1

Two new Membership Categories were finalised in November 2012 . Observer Member . ... ISO 13485(MDMS) ISO 50001(EnergyMS) 1.5 0.9 ... and EnMS, Nr. of certificate of En MS is still small. Trends in Regional Share (QMS) Source: ISO Survey -2011. 269,332. 492,248. Europe

http://www.itu.int/en/ITU-T/Workshops-and-Seminars/conformity-interoperability/201311/Documents/S5P3_Venkat_PAC%20presentation-ITU-UNIDO%20program,Yangon-Nov2013.pptx

Date added: January 6, 2014 - Views: 11

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ISO TC 207 and ISO TC 176 – Trends for future Ahmad ...

... of any future ISO management system standard ... ISO/TS 16949 – ISO 9000 Automotive ISO/TS 29001 – ISO 9000 Oil and Gas ISO/IEC 17025 – Laboratories (and ISO 9000) ISO 13485 ... (EFQM) Business Excellence Model Charles Corrie, Tunis, Participation Forum, 2013-11 ISO 22301:2012 ...

http://www.tounesonline.com/Interventionsjqm2013en/Charles%20Corrie-%20Intervention%202013%20En.ppt

Date added: July 28, 2014 - Views: 1

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Diapositiva 1 - Alifax S.P.A.

16,01,2012. Chapter 1. Erythrocyte Sedimentation Rate. ... Procedures for the Erythrocyte Sedimentation Rate Test; Approved standard- 5th Edition ... The new EN ISO 13485:2003 certification (GMP) ...

http://www.alifaxgroup.com/search_download.asp?id=:74hojsutuqjsd

Date added: February 4, 2014 - Views: 9

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Overview of TGF PSM Policies - Home - The Global Fund to ...

compliant with ISO 13485 (except for microscopes for which ISO9000 applies) Malaria ... (ISO 2859-1) QC testing is done by . ISO 17025 certified laboratory ... according to appropriate standard operating procedure.

http://www.theglobalfund.org/documents/regional_meetings/2014-03-02-jordan/Event_2014-03-02-RM-MENA-16-PSM_Presentation_en/

Date added: April 11, 2014 - Views: 11

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Diapositiva 1 - PAHO

... and as new aspects standard introduces the concept of ... Bearing in mind the International Standards ISO 13485 and ISO 14971. Directive 93/42/EEC, and ... Comprehensive guide to the Global Medical Device Nomenclature ( ISO 15225 de 1997 - ultima versión 2012. ISO TS ...

http://www.paho.org/hq/index.php?option=com_docman&task=doc_download&gid=22917&Itemid=270&lang=en

Date added: December 20, 2013 - Views: 20

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Download - Home - Pan American Health Organization

... and ANVISA (Brazil) signed a Statement of Cooperation (November 2012) to commit to the ... The IMDRF Work Group is working on various components of the MDSAP model The Work Group will develop a standard set of requirements ... * MDSAP Manufacturer Audit Criteria ISO 13485:2003 ...

http://www.paho.org/hq/index.php?option=com_docman&task=doc_download&gid=22912&Itemid=1335&lang=en

Date added: December 8, 2013 - Views: 10

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Diapositiva 1 - UK HealthGateway

... most recently ‘Strengthening Our National System For Medical Device Postmarket Surveillance’ published September 2012. ... EN ISO 14971: 2009 Medical devices ... Do work within a QMS to ISO 13485 so you can prove to YOURSELF and any inspector/auditor that you are in .

http://www.ukhealthgateway.com/wp-content/uploads/2012/09/Trevor-Lewis1.pptx

Date added: February 6, 2013 - Views: 16

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Systèmes de management - Archives de la Dgcis : Les anciens ...

... norme internationale ISO/FDIS : ISO / FDIS : (F) DIS (Final) Draft International Standard - documents informatifs TR : rapport technique 1. Responsabilité de ... Amélioration NF EN ISO 13485 : 2004 Dispositifs médicaux - Système de management de la qualité - Exigences ...

http://archives.entreprises.gouv.fr/2012/www.industrie.gouv.fr/portail/pratique/management.ppt

Date added: July 4, 2014 - Views: 1

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PowerPoint Presentation

... and to develop affordable and manufacturing-ready prototypes in compliance with medical standard and process. ... 2012 2013 2014 99.4 121.3 150.80000000000001 185.6 ... (ISO 13485) Cuff-less Blood Pressure Measurement. Non-invasive Glucose Monitoring.

http://www.itc.gov.hk/en/doc/download/ASTRI's_Telehealth_KTI_Proposal_for_TC-Sep2010.pptx

Date added: January 25, 2013 - Views: 15

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Movendos ppt - TUT

EN 62366 Medical devices. ... ISO 14971 Medical Devices-Application of risk management to medical devices . ISO 13485 Medical Devices. Quality management systems. Requirements for regulatory purposes. 12/11/2013 ... Jan-2012. May-2012. Jan-2013.

http://www.cs.tut.fi/tapahtumat/SoftwareStartupDay/StefanBaggstrom.pptx

Date added: January 6, 2014 - Views: 10

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Diapositive 1 - Cofrac - Comité français d'accréditation

... n°600/2012 NF EN ISO 14065:2013 (très peu de changements par ... (ISO 9001 ; ISO 14001 ; ISO 27001 ; ISO 13485) ... OC + règles de certif de l’OC éventuelles Code de la consommation Poutrelles en béton Code de la consommation + standard technique NF EN 15037-1 + modalités de ...

http://www.cofrac.fr/site/content/french/pages/home/docs/forum_certification_2013/6eme_FORUM_CERTIFICATIONS_25092013.ppt

Date added: October 24, 2013 - Views: 18

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Presentación de PowerPoint - Bienvenido a Prodecal

... que sustituye a la ISO 19011:2002. Año 2012: Se comienza a ... “SGC. Requisitos” ISO 14001:2004, “SGA. Requisitos” Sectoriales: ISO 13485: 2003 “Equipos médicos. SGC ... Ginebra, Suiza. Creación: 23 de febrero de 1947. En ISO están representados los ...

http://www.prodecal.cl/areatecnica/2012/ISO%209001%20%202008%20Alejandro%20Penabad.ppt

Date added: September 21, 2013 - Views: 33

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Tecnologia, Innovazione, Qualità - Deim

Si analizzano poi i punti critici dove operare i controlli per garantire il rispetto degli standard previsti ... con riferimento alla sicurezza 12973:2003 gestione del valore” UNI EN ISO 13485:2004 ... Principi generali” UNI EN ISO 14021:2012 “Etichette e dichiarazioni ambientali ...

http://www.deim.unitus.it/web/scaricatore.asp?c=rrvff3e1196x02v2ow3xii5r4&par=1

Date added: November 12, 2013 - Views: 23

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Tecnologia, Innovazione, Qualità - Piattaforma Unica della ...

Si analizzano poi i punti critici dove operare i controlli per garantire il rispetto degli standard previsti ... Principi generali” UNI EN ISO 14021:2012 “Etichette e ... 2010 5 5 UNI EN 9120:2010 16 16 UNI EN ISO 13485:2004 1994 1690 UNI EN ISO 14001:2004 16113 9162 ...

http://www.didattica.unitus.it/web/scaricatore.asp?c=4ugunqae06zpl3k25spg5r7mq&par=1

Date added: March 13, 2014 - Views: 11

ppt
Slide 1

16th October 2012 £185 + VAT at 20% (UK ... ISO 9001: 2008 ISO 13485: 2003 CD 1363/17 ... ITU networks, etc. Until recently, the safety of medical electrical systems were dealt with in the separate collateral standard BS EN 60601-1-1:2001.

http://www.liv.ac.uk/~clfs12/NHS%20Dept%20Clinical%20Engineering%20Liverpool/Electrical_safety_short_courses/CD1363_17%20Short%20Courses%20Brochure.ppt

Date added: March 31, 2013 - Views: 13

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Diapositiva 1

... medycznych Norma ISO 15224:2013-Usługi sektora ochrony zdrowia -Systemy zarządzania jakością -Wymagania oparte na EN ISO 9001:2008 http://www.iso.org/iso/home ... Największa zaleta- „ISO to nie standard lecz droga do ... ISO 13485/13488-standardami dla systemów ...

http://www.rynekzdrowia.pl/Pliki/136749.html

Date added: June 3, 2014 - Views: 1

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Tecnologia, Innovazione, Qualità - Deim

Si analizzano poi i punti critici dove operare i controlli per garantire il rispetto degli standard previsti nel sistema qualità. ... con riferimento alla sicurezza 12973:2003 gestione del valore” UNI EN ISO 13485:2004 ... nello spazio e nella difesa ISO/IEC 17020:2012 Ispezioni ...

http://www.deim.unitus.it/web/scaricatore.asp?c=hoc6fet7t8ha223ho8f5wgnpn&par=1

Date added: July 24, 2014 - Views: 1

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Sintel - eProcurement in Lombardia - Home Page - Camera di ...

... Entrate Certificato casellario giudiziale disciplinato dal D.P.R. 313/2002 Certificato D.U.R.C. Certificazione UNI EN ISO 9001:2008 Altro Certificazioni mediche: Certificazione dispositivi medici UNI EN ISO 13485:2004 ... Serie ISO 14001:2004 Certificazione Standard Energy Star (o ...

http://www.va.camcom.it/files/innovaz/110719_Corso_Sintel_CCIAA_Varese.ppt

Date added: May 2, 2013 - Views: 10

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1. dia - Nemzeti Akkreditáló Testület - NAT - Budapest ...

Az irányítási rendszerek tanúsítása területén bevont minősítők és szakértők képzése az MSZ EN ISO/IEC 17021:2011 szabványról ... (ISO 13485) IAF ID 1:2010 ... Draft International Standard (ISO) FDIS: Final Draft International Standard (ISO) ISO/IEC 17021 Felülvizsgálata Az ...

http://www.nat.hu/ckfinder/fajlok/files/2011-10-18.ppt

Date added: June 12, 2013 - Views: 15

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Diapositive 1 - univ-lille2.fr

... certification sur les tests, la mise en œuvre de ces test, ... Biomarkers Development Plan 2007 -> 2012 Co-funded The development of a companion test for BN83495; ... GMP, ISO 9001, ISO 13485, Manufacturing license class III ...

http://campus2.univ-lille2.fr/claroline/backends/download.php?url=L0JJT01FUklFVVhfMjAxMC5wcHQ%3D&cidReset=true&cidReq=ANMODIND

Date added: May 2, 2013 - Views: 22

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PowerPoint Presentation

/ ISO 13485, ISO 9001, EN46001. 60601-1. 60601-1-1. 60601-2-1. 60601-2-2. 60601-2-38. 60601-1-2. 60601-1-4. 60601-1-3. General Standard. Collateral Standards. 60601-2-50. Particular Standards. Medical Systems. EMC. Radiation Protection. Software. ... http://www.aalto.fi/en/current/news/view/2012 ...

http://www.pclhvs.cl.edu.tw/mediafile/14520038/fdownload/41/68/2014-3-30-17-20-1-68-nf1.pptx

Date added: August 1, 2014 - Views: 1

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Folie 1

... insbesondere aus der Qualitätsmanagement-Norm ISO 13485. ... (en) Beschreibung Formel Daten-Quelle Abarbeitungs-geschwindigkeit für CAPA Nicht das Feststellen von Abweichungen und ... 4 08.02.2012 W. Siegmund Änderungen nach internem Audit auf den QM-Prozess ...

http://www.new-media-communication.de/fu+moe_gmbh/content/QM/PB%20Interne%20Audits.pps

Date added: December 27, 2012 - Views: 7

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LU_KVS - Latvijas Universitātes Bioloģijas fakultāte

... 3.2.10,3.2.11, 3.2.12) KVALITĀTES SISTĒMAS. Kvalitātes vadības sistēmu standarti, vēsture. 4.izdevums – LVS EN ISO 9001:2009 “Kvalitātes ... Kvalitātes sistēmu sertifikācija pasaulē. ISO 13485:2003 “Medical devices- Quality management ... April 16, 2012 As ...

http://priede.bf.lu.lv/ftp/grozs/Mikrobiologijas/Ancans/Bioanalitika%202013/Mezinska_LU_Biol_mg_21_03_2013.ppt

Date added: July 28, 2013 - Views: 4

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Grundlagen der Gesundheitsökonomik - Jura & WiWi ...

Juni 2005 in der Fassung vom 16. August 2012. Ärztliche Weiterbildung. Zusatzbezeichnungen. Ärztliches Qualitätsmanagement. Akupunktur. Allergologie. Andrologie. Balneologie und Medizinische Klimatologie. ... Standard: Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) ... EN ISO ...

http://www.rsf.uni-greifswald.de/fileadmin/mediapool/lehrstuehle/flessa/GM_2/GM_2_SoSe_2014/GM_II__Teil_2.pptx

Date added: April 3, 2014 - Views: 1

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Introduction of the “One-Desk” Principle in Capital ...

... including the administration of local taxes and costs of the service Developing standard printed feedback form for studying the public opinion on administrative services By the end of ... ISO Standards. http://www.iso.org/iso/en/ISOOnline.frontpage. ... ISO 13485:2003 certifications ...

http://www.csd.bg/fileSrc.php?id=2239

Date added: August 1, 2013 - Views: 12

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EUROPEAN INNOVATION PARTNERSHIP ON ACTIVE AND HEALTHY AGEING

... (Italy), Ikerlan S.Coop (Spain), Stichting Verpleging en Verzorging Eindhoven e.o. De Archipel (Netherlands), Provincia Autonoma di ... The result of this process is foreseen for 2012; ... Produktlösungen für elektronische Akten basieren fast durchgängig auf dem IHE XDS Standard, ...

http://argos.eurorec.org/budapest_11may2011/documents/12_ARGOS_IliasIakovidis.ppt

Date added: June 27, 2012 - Views: 225

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Diapositiva 1 - Dipartimento di Ingegneria dell'Informazione

... (elaborata dall’ISO o, per il settore elettrico ... Controllo dei Rischi Valutazione del rischio residuo Informazioni di produzione e post produzione Norma Tecnica EN 13485 ... Ottimizzazione Acquisti Mantenimento standard di qualità e sicurezza INTRODUZIONE 1.1 Ma oggi è ...

http://www.iet.unipi.it/p.donati/files/2012/LUCIDI_PARTE_I.ppt

Date added: June 26, 2012 - Views: 29

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Slide 1

... Michigan based company Sells engineering standards online 90% of site visitors enter a search immediately A technical standard A Techstreet document number An area of interest Techstreet Log Analysis Other Universities Compared with Ohio State and Northwestern Same curve Similar search terms ...

http://www.infotoday.com/it2003/presentations/Wiggins.pps

Date added: November 12, 2012 - Views: 655

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Enjeux : maîtrise médicalisée - Accueil

Une Phase test préalable pour en valider l’efficacité, à échelle réduite (1/20ème), ... 5.3.Grosse imprimante, photocopieurs, standard, fax.. 5.2. Réseaux, serveurs, ... 3161525 SOL ISO PHENOLEE STALLERGENES 1/9 ML.

http://pouruneprescriptionplusefficientedumedicament.pagesperso-orange.fr/documents/Progenerix%20-%20PUPPEM-DiaposV6.ppt

Date added: May 2, 2013 - Views: 54