risk-analysis, DIN 14971, risk-management, medical-devices
Risko analysis, DIN 14971, Risk management Medical devices, In-Vitro-Diagnostics, IVD DEUTSCH | IMPRINT 15.05.2008 FDA notification, CE-marking, EN 1441 Qware Riskmanager
risk-analysis, DIN 14971, risk-management, medical-devices
seminars software market analysis accomodation certification notified body product lifecyclerisk management report Risk analysis of medical devices DIN EN ISO 14971
admission of medical products implementation of risk management for medical devices harmonized norm
harmonized norm DIN EN 14971
accomodation certification notified body
 implementation of a risk analysis risk management normative law regulations
Likelihood and severity evaluation after measures
DIN EN ISO 14971:2000
assignment with DIN EN ISO 13485_2003
product process severity measures evaluation likelihood
life cycle time line implement system requirements  practical application
 directive 93/42/EWG risk evaluation and for risk control
New functions in Qware Riskmanager 2.5
Visit us at the Medica 2006 Visit us at the Würzburger Medizintechnik Kongress fbmt 2007
In-Vitro-Diagnostics IVD FDA authorization CE-marking

References - Qware Riskmanager

product lifecycleQware Riskmanager In-Vitro-Diagnostics Medizinprodukte
Regualtory Affairs likelihood of appearing a damage Qware Riskmanager 2.5

Abstract of the current reference list of Qware Riskmanager

Below you can have a look on an abstract of our current references and check which companies already trust in the market leading risk management software according to the DIN EN ISO 14971.

  Download references as pdf File

  • ABX, Montpellier, France
  • AdnaGen AG, Langenhagen, Germany
  • AEROCRINE AB, Solna, Sweden
  • AESKU.DIAGNOSTICS GmbH, Wendelsheim, Germany
  • B.Braun Medical Hungary Ltd., Budapest, Hungary
  • B.Braun Medizintechnologie GmbH, Melsungen, Germany
  • B.Braun Melsungen AG, Melsungen, Germany
  • B.R.A.H.M.S. AG, Hennigsdorf, Germany
  • Barkey GmbH & Co. KG, Leopoldshöhe, Germany
  • Berlin Heart GmbH, Berlin, Germany
  • Berthold Detection Systems GmbH, Pforzheim, Germany
  • BEZNOSKA s.r.o., Kladno, Czech
  • Biocode-Hycel France SA, POUILLY-EN-AUXOUIS, France
  • Bioengineering Laboratories S.p.A., Cantu, Italy
  • BioTissue Technologies GmbH, Freiburg, Germany
  • Bruker Elektronik GmbH, Rheinstetten, Germany
  • bs Management GmbH, Hennigsdorf, Germany
  • Charité Campus Virchow-Klinikum, Berlin, Germany
  • CHROMSYSTEMS Instruments & Chemicals, München, Germany
  • CIBA Vision GmbH, Großwallstadt, Germany
  • Compumedics Germany GmbH, Singen, Germany
  • Consulting & more, Bensheim, Germany
  • Contec Steuerungstechnik u. Automation GesmbH, Kufstein Ebbs, Austria
  • Coripharm Medizinprodukte GmbH&Co.KG, Dieburg, Germany
  • Corus Aluminium Walzprodukte GmbH, Koblenz, Germany
  • Cosmedico Medizintechnik GmbH, VS-Schwenningen, Germany
  • Crescendas IBP AG, Hannover, Germany
  • Dade Behring Marburg GmbH, Schwalbach, Germany
  • Denkendorf (DITF), Denkendorf, Germany
  • Derungs Licht AG, Gossau, Switzerland
  • DiaSorin Deutschland GmbH, Dietzenbach, Germany
  • Donawa & Associates Ltd., Rome, Italy
  • Dreve ProDiMed GmbH, Unna, Germany
  • Eldith GmbH, Illmenau, Germany
  • ELMAG GmbH, München, Germany
  • Embedded System Engineering GmbH, Stockach, Germany
  • en.co.tec Schmid KEG, Wien, Austria
  • Ension Inc., Pittsburgh, PA, USA
  • Epitek Inc., Bloomington, MN, USA
  • Euro Allianz Pharma GmbH, Hamburg, Germany
  • Euro Risk Limited, Zürich, Switzerland
  • EUROCAT GmbH, Darmstadt, Germany
  • Fachhochschule Stralsund, Stralsund, Germany
  • Forschungszentrum Karlsruhe GmbH, Eggenstein-Leopoldshafen, Germany
  • Franz Wilhelm Langguth Erben GmbH & Co. KG, Traben-Trarbach, Germany
  • Fraunhofer-Institut für Biomedizinische Technik, St. Ingbert, Germany
  • Fresenius HemoCare Netherlands B.V., HM Emmer-Compascuum, Netherland
  • Fresenius Kabi Deutschland GmbH, Bad Homburg, Germany
  • Fresenius Kabi Deutschland GmbH, Friedberg, Germany
  • Fresenius Medical Care Deutschland GmbH, Bad Homburg, Germany
  • Fresenius Transfusions GmbH, Friedberg, Germany
  • FRIADENT GmbH, Mannheim, Germany
  • Ganshorn Medizin Electronic GmbH, Niederlauer, Germany
  • Gebrüder Martin GmbH & Co. KG, Tuttlingen, Germany
  • Gero Dannert, Buchholz, Germany
  • GeTeMed Medizin- und Informationstechnik AG, Teltow, Germany
  • GymnaUniphy N.V., Bilzen, Belgium
  • Haleko GmbH & Co. OHG , Hamburg, Germany
  • Herbert Waldmann GmbH & Co. KG, Villingen-Schwenningen, Germany
  • HEWI Heinrich Wilke GmbH, Bad Arolsen, Germany
  • HEYL Chemisch-pharmazeutische Fabrik, Berlin, Germany
  • HighMedic GmbH, Lehrte, Germany
  • Hoyer-Madaus GmbH & Co. KG, Monheim, Germany
  • I.T.S. GmbH, Laßnitzhöhe, Austria
  • Imfeld Unternehmensberatung GmbH, Bätterkinden, Switzerland
  • Ing. Erich Pfeiffer GmbH, Radolfzell, Germany
  • Inion Ltd., Tampere, Finland
  • Innomed International AG, Triesen, Finland
  • INQ - Ingenieurbüro Niebel, Halsenbach, Germany
  • Intelligent Implants GmbH, Bonn, Germany
  • International Medical Care GmbH, Emsdetten, Germany
  • intromed Medizintechnik GmbH, Senzig, Germany
  • ITD GmbH, Unterhaching, Germany
  • ITV Denkendorf Produktservice GmbH, Denkendorf, Germany
  • Karl Leibinger Medizintechnik GmbH & Co. KG, Mühlheim, Germany
  • KLS Martin GmbH & Co KG, Umkirch, Germany
  • Kräuterhaus Sanct Bernhard KG, Bad Ditzenbach, Germany
  • Leica Microsystems CMS GmbH, Wetzlar, Germany
  • Likamed GmbH, Eppingen, Germany
  • LINEA GmbH, Aachen, Germany
  • LOGICA Medizintechnik GmbH, Oldenburg, Germany
  • LS Medizin Service Gesellschaft mbH, Ettlingen, Germany
  • M&K Therapiegeräte GmbH & Co. Vertrieb KG, Staufenberg, Germany
  • Maico Diagnostic GmbH, Berlin, Germany
  • MAQUET GmbH & Co. KG, Rastatt, Germany
  • MAT Adsorption Technologies GmbH & Co. KG, Obernburg, Germany
  • MedCom , Darmstadt, Germany
  • Medela AG, Medical Technology, Baar, Switzerland
  • MEDICON eG, Tuttlingen, Germany
  • Medinorm Medizintechnik GmbH, Spiesen-Elversberg, Germany
  • Medizinische Hochschule Hannover, Hannover, Germany
  • Medizintechnik Basler AG, Regensdorf, Switzerland
  • Medos AG, Langenselbold, Germany
  • Medtron AG, Saarbrücken, Germany
  • MeDys GmbH, Bad Ditzenbach, Germany
  • Merck KGaA, Darmstadt, Germany
  • Meß- und Regeltechnik Poduschka, Erftstadt, Germany
  • Metrax GmbH, Rottweil, Germany
  • MeVis Diagnostics GmbH, Bremen, Germany
  • Meyer Limited Sti, Ümraniye / Istanbul, Turkey
  • MF Tech GmbH, Oberrüti, Switzerland
  • miro Verbandstoffe GmbH, Wiehl-Drabenderhöhe, Germany
  • Möller Medical GmbH & Co KG, Fulda, Germany
  • MONDEAL Medical Systems GmbH, Tuttlingen, Germany
  • MST Instrumente GmbH, Dürbheim, Germany
  • MTAG MARTI-TECHNOLOGIE AG, Emmenbrücke, Switzerland
  • MTM Laboratories AG, Heidelberg, Germany
  • Mundipharma GmbH, Limburg, Germany
  • N.G.C. MEDICAL S.p.A., Novedrate (CO), Italy
  • NESTEC SA, Vevey, Switzerland
  • NeuroTech S.A., Louvain-la-Neuve, Belgium
  • Nexus AG, VS-Villingen, Germany
  • Oertli Instrumente AG, Berneck, Switzerland
  • ONDAL, Hünfeld, Germany
  • ORGENTEC Diagnostika GmbH, Mainz, Germany
  • Ortho Apply Innovation BV, Gravenhage, Netherland
  • Ossacur AG, Oberstenfeld, Germany
  • Otto Bock Healthcare Products GmbH, Wien, Austria
  • PARI GmbH, Starnberg, Germany
  • pes diagnosesysteme GmbH, Leipzig-Markkleeberg, Germany
  • Pharmacia Production B.V., Groningen, Netherland
  • Positronic Beam Service GmbH, Rellingen, Germany
  • Pulsion Medical Systems AG, München, Germany
  • Qiagen GmbH, Hilden, Germany
  • Qiagen Instruments AG, Hombrechtikon, Switzerland
  • Q-Kon Unternehmensberatung, Niederfischbach, Germany
  • R-Biopharm AG, Darmstadt, Germany
  • Reinecker Reha-Technik GmbH, Alsbach-Hähnlein, Germany
  • ROI Computer AG, Roding, Germany
  • Rudolf Buck GmbH, Wurmlingen, Germany
  • Salvia Lifetec GmbH & Co. KG, Kronberg, Germany
  • Sartorius AG, Göttingen, Germany
  • Schering AG, Berlin, Germany
  • Schmitz & Söhne GmbH & Co. KG, Bönen, Germany
  • Seleon GmbH, Dessau, Germany
  • Sensovation AG, Stockach, Germany
  • SIS Surgical Instrument Systems Ltd., Port, Switzerland
  • Smith & Nephew Orthopaedics GmbH, Tuttlingen, Germany
  • Somatex Medical Technologies GmbH, Teltow, Germany
  • Storz Endoskop Produktions GmbH, Schaffhausen, Switzerland
  • Storz Medical AG, Kreuzlingen, Switzerland
  • Stuckenbrock Medizintechnik GmbH, Tuttlingen, Germany
  • Swandale Holdings Pty. Ltd., Straubenhardt, Germany
  • Technische Unternehmensberatung, Rödermark, Germany
  • TECO Medical Instruments GmbH, Neufahrn N.B., Germany
  • Thomas Recording GmbH, Gießen-Europaviertel, Germany
  • Transasia Biomedicals Ltd., Mumbai, India
  • Trinity Biotech GmbH, Lemgo, Germany
  • TRUMPF Medizinsysteme GmbH, Saalfeld, Germany
  • TÜV SÜD Industrie Service GmbH, Leipzig, Germany
  • U.T.E. Srl, Trento, Italy
  • Uromedica, Inc., Plymouth, USA
  • URS Universal Robot Systems, Schwerin, Germany
  • V. Krütten, Idstein, Germany
  • Varian Medical Systems Haan GmbH, Haan, Germany
  • VEGA Grieshaber KG, Schiltach, Germany
  • Vestfold Audio AS, Sandefjord, Norway
  • Vital Base AS, Hareid, Norway
  • Vivonic GmbH, Sailauf, Germany
  • Völker GmbH, Hainichen, Germany
  • W & H Dentalwerk Bürmoos GmbH, Bürmoos, Austria
  • Waldemar Link GmbH & Co, Hamburg, Germany
  • Wilden AG, Pfreimd, Germany
  • Wilfried Krömker GmbH, Bückeburg, Germany
  • zebris Medical GmbH, Isny, Germany
  • Zimmer Elektromedizin GmbH, Neu-Ulm, Germany


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Medica 2006
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Visit us at the Medica 2006 in Düsseldorf. To prevent waiting time arrange a date wit one of our consultants.
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