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References

Below you will find an overview of selected companies which have already successfully adopted Qware® Riskmanager, the world’s leading software solution for the creation of technical documentation for manufacturers of medical devices and in-vitro diagnostic devices.
In addition to the creation of risk management files conforming to ISO 12971:2012, usability engineering files conforming to IEC EN 60601-1-6 / IEC 62366, compliance reports for medical electric equipment according to IEC 60601-1, 3rd edition, and essential requirements in accordance with MDD 93/42/EEC und IVDD 98/79/EC, Qware® Riskmanager also features a fully integrated requirements engineering module.
Qware® Riskmanager helps to detect risks early in the development process and to visualize risk distributions graphically. The intuitive user interface, bundled examples, and prepared document templates make it easy to get started. The self-learning knowledge base with automatic suggestions of further potential risks, possible sources, or the most efficient measures, facilitates the use of synergies between projects and accrued know-how across the whole company.
For 16 years Qware® Riskmanager has successfully proven itself on the market, has been continuously adapted to normative changes and has been enhanced with new functionality. As an immediately useable, market-established, and cost-effective system, it accelerates development and approval processes. You spend your time on content, not on form.

  • AAT Alber Antriebstechnik GmbH / Albstadt / Germany
  • ABX / Montpellier / France
  • Adaltis Italia SPA / Casaleccio di Reno / Italy
  • aditus V GmbH / Berlin / Germany
  • AdnaGen GmbH / Langenhagen / Germany
  • Advanced Medical Technologies AG / Nonnweiler / Germany
  • AEROCRINE AB / Solna / Sweden
  • AESKU.DIAGNOSTICS GmbH / Wendelsheim / Germany
  • ALFATEC / Tuttlingen / Germany
  • Aptar Radolfzell GmbH / Radolfzell / Germany
  • Arbios Systems Inc. / Waltham, MA / USA
  • ARGES Gesellschaft für Industrieplanung und Lasertechnik mbH / Wackersdorf / Germany
  • ARTEION / Paris / France
  • ASSKEA GmbH / Gebesee / Germany
  • B.Braun Avitum AG / Melsungen / Germany
  • B.Braun Avitum Saxonia GmbH / Radeberg / Germany
  • B.Braun Medical Hungary Ltd. / Budapest / Hungary
  • B.Braun Melsungen AG / Melsungen / Germany
  • B.R.A.H.M.S. AG / Hennigsdorf / Germany
  • Barkey GmbH & Co. KG / Leopoldshöhe / Germany
  • BEGO Bremer Goldschlägerei GmbH & Co. KG / Bremen / Germany
  • Belimed Sauter AG / Sulgen / Switzerland
  • Berlin Heart GmbH / Berlin / Germany
  • Bernafon AG / Bern / Switzerland
  • Berthold Detection Systems GmbH / Pforzheim / Germany
  • Berufliche Schule des Wetteraukreises in Butzbach / Butzbach / Germany
  • BEZNOSKA s.r.o. / Kladno / Czech Republic
  • Biocode-Hycel France SA / POUILLY-EN-AUXOUIS / France
  • Bioengineering Laboratories S.p.A. / Cantu / Italy
  • BioTissue Technologies GmbH / Freiburg / Germany
  • Biregs GmbH & Co.KG / Oberursel / Germany
  • BLANCO CS GmbH + Co KG / Oberderdingen / Germany
  • Bruker-Physik GmbH / Ettlingen / Germany
  • bs Management GmbH / Hennigsdorf / Germany
  • BYTEC Medizintechnik GmbH / Eschweiler / Germany
  • Centre de Recherche Public Henri Tudor / Luxembourg-Kirchberg / Luxembourg
  • CEZANNE SAS / NIMES Cedex 01 / France
  • Charité Campus Virchow-Klinikum / Berlin / Germany
  • CHROMSYSTEMS Instruments & Chemicals GmbH / Gräfelfing / Germany
  • CIBA Vision GmbH / Großwallstadt / Germany
  • CIM med GmbH / München / Germany
  • Compumedics Germany GmbH / Singen / Germany
  • Contec Steuerungstechnik u. Automation Ges. mbH / Kufstein Ebbs / Austria
  • Coripharm Medizinprodukte GmbH&Co.KG / Dieburg / Germany
  • Corus Aluminium Walzprodukte GmbH / Koblenz / Germany
  • Cosmedico Licht GmbH / Stuttgart / Germany
  • Cosmetic Service AG / Eppertshausen / Germany
  • Crescendas IBP AG / Hannover / Germany
  • CTC Analytics AG / Zwingen / Switzerland
  • DATAMED s.r.l. / Rodano (Milano) / Italy
  • Derungs Licht AG / Gossau / Switzerland
  • Deutsche Institute für Textil- und Faserforschung Denkendorf (DITF) / Denkendorf / Germany
  • Deutsches Krebsforschungszentrum / Heidelberg / Germany
  • DiaSorin Deutschland GmbH / Dietzenbach / Germany
  • DIERS International GmbH / Schlangenbad / Germany
  • Dometic S.à r.l. / Hosingen / Luxembourg
  • Donawa & Associates Ltd. / Rome / Italy
  • Dr. Harald Rus / Steinach / Austria
  • Dr. Schmoranzer GmbH / Wien / Austria
  • Dräger Medical GmbH / Lübeck / Germany
  • Dreve ProDiMed GmbH / Unna / Germany
  • EC-Consulting / Bad Sobernheim / Germany
  • ELMAG GmbH / München / Germany
  • Epitek Inc. / Bloomington, MN / USA
  • Escatec Switzerland / Heerbrugg / Switzerland
  • Euro Allianz Pharma GmbH / Hamburg / Germany
  • EyeSense GmbH / Großostheim / Germany
  • eZono AG / Jena / Germany
  • Fachhochschule Münster / Steinfurt / Germany
  • Fachhochschule Stralsund / Stralsund / Germany
  • FIOR & GENTZ GmbH / Lünbeburg / Germany
  • FMW electronic OHG / Inzigkofen / Germany
  • Franz Wilhelm Langguth Erben GmbH & Co. KG / Traben-Trarbach / Germany
  • Fraunhofer-Institut für Biomedizinische Technik / St. Ingbert / Germany
  • Fraunhofer-Institut für Integrierte Schaltungen / Erlangen / Germany
  • Fresenius HemoCare Netherlands B.V. / HM Emmer-Compascuum / The Netherlands
  • Fresenius Kabi Deutschland GmbH / Friedberg / Germany
  • Fresenius Kabi Deutschland GmbH / Bad Hersfeld / Germany
  • Fresenius Medical Care Deutschland GmbH / Bad Homburg / Germany
  • FRIADENT GmbH / Mannheim / Germany
  • Fritz Ruck Ophthalmologische Systeme GmbH / Eschweiler / Germany
  • GAMPT mbH / Merseburg / 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
  • GILUPI GmbH / Potsdam / Germany
  • GPE-Holding GmbH / Wacken / Germany
  • Greiner Bio-One GmbH / Frickenhausen / Germany
  • GymnaUniphy N.V. / Bilzen / Belgium
  • H&S Qualità nel Software S.p.A. / Milano / Italy
  • H. P. Braem AG / Mörschwil / Switzerland
  • h/p/cosmos sports & medical gmbh / Nussdorf-Traunstein / Germany
  • Haleko GmbH & Co. OHG / Hamburg / Germany
  • HAMILTON Bonaduz AG / Bonaduz / Switzerland
  • handicare AS / Moss / Norway
  • Heraeus Kulzer GmbH / Hanau / Germany
  • Herbert Waldmann GmbH & Co. KG / Villingen-Schwenningen / Germany
  • HEWI Heinrich Wilke GmbH / Bad Arolsen / Germany
  • HEYL Chemisch-pharmazeutische Fabrik GmbH & Co. KG / Berlin / Germany
  • HighMedic GmbH / Lehrte / Germany
  • HJS GmbH & Co. KG / Salzkotten / Germany
  • Horst Scholz GmbH + Co. KG / Kronach / Germany
  • Hoyer-Madaus GmbH & Co. KG / Monheim / Germany
  • Hubertus Goller Gesellschaft m.b.H. / Klosterneuburg / Austria
  • I.T.S. GmbH / Laßnitzhöhe / Austria
  • IDS Immunodiagnostic Systems / POUILLY-EN-AUXOIS / France
  • Ifolor AG / Kreuzlingen / Switzerland
  • ILCON GmbH / Hoya / Germany
  • Inion Ltd. / Tampere / Finland
  • inmedis GmbH / Zug / Switzerland
  • Innomed International AG / Triesen / The Principality of Liechtenstein
  • INQ - Ingenieurbüro Niebel / Halsenbach / Germany
  • Intelligent Implants GmbH / Bonn / Germany
  • International Medical Care GmbH / Emsdetten / Germany
  • intromed Medizintechnik GmbH / Wildau / Germany
  • IROC Innocross AG / Zürich / Switzerland
  • ITD GmbH / Unterhaching / Germany
  • ITV Denkendorf Produktservice GmbH / Denkendorf / Germany
  • Joanneum Research Forschungsgesellschaft mbH / Graz / Austria
  • Kantonsspital Graubünden / Chur / Switzerland
  • Karl Leibinger Medizintechnik GmbH & Co. KG / Mühlheim / Germany
  • Karlsruher Insitut für Technologie Campus Nord / Eggenstein-Leopoldshafen / Germany
  • KLS Martin GmbH & Co KG / Umkirch / Germany
  • Kräuterhaus Sanct Bernhard KG / Bad Ditzenbach / Germany
  • KUKA Roboter GmbH / Augsburg / Germany
  • Leibniz Universität Hannover / Hannover / Germany
  • Leica Microsystems CMS GmbH / Wetzlar / Germany
  • LES Langen Electronic Systems GmbH / Viersen / Germany
  • LEVO AG / Wohlen / Switzerland
  • LightGuideOptics Germany GmbH / Rheinbach / Germany
  • Likamed GmbH / Eppingen / Germany
  • Limmer Laser GmbH / Berlin / Germany
  • LOGICA Medizintechnik GmbH / Oldenburg / Germany
  • Löns Apotheke / Buchholz / Germany
  • LRE Medical GmbH / München / Germany
  • LS Medizin Service Gesellschaft mbH / Ettlingen / Germany
  • Maico Diagnostic GmbH / Berlin / Germany
  • MAQUET GmbH & Co. KG / Rastatt / Germany
  • MAT Adsorption Technologies GmbH & Co. KG / Obernburg / Germany
  • MCS MICRONIC Computer Systeme GmbH / Berlin / Germany
  • Med bone - Medical Devices Unip LDA / Alcabideche-Cascais / Portugal
  • MedCom Gesellschaft für medizinische Bildverarbeitung mbH / Darmstadt / Germany
  • Medela AG, Medical Technology / Baar / Switzerland
  • MEDICON eG / Tuttlingen / Germany
  • mediDOK Software-Entwicklungsgesellschaft mbH / Dossenheim / Germany
  • Medinorm Medizintechnik GmbH / Spiesen-Elversberg / Germany
  • Medizintechnik Basler AG / Regensdorf / Switzerland
  • medlab medizinische Diagnosegeräte GmbH / Stutensee / Germany
  • Medtron AG / Saarbrücken / Germany
  • MeDys GmbH / Gruibingen / Germany
  • Merck KGaA / Darmstadt / Germany
  • Meß- und Regeltechnik Poduschka / Erftstadt / Germany
  • Messer Austria GmbH / Gumpoldskirchen / Austria
  • Messer Schweiz AG / Lenzburg / Switzerland
  • Metrax GmbH / Rottweil / Germany
  • MeVis gGmbH / Bremen / Germany
  • MeVis Medical Solutions AG / 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 / Mühlheim a. d. Donau / 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
  • neuroConn GmbH / Illmenau / Germany
  • NeuroTech S.A. / Louvain-la-Neuve / Belgium
  • Nexus AG / VS-Villingen / Germany
  • nexus/dis GmbH / Frankfurt am Main / Germany
  • Nikkiso Europe GmbH / Hannover / Germany
  • NORMED Medizin-Technik GmbH / Tuttlingen / Germany
  • Oertli Instrumente AG / Berneck / Switzerland
  • OFFICINA DI PROTESI TRENTO s.p.a. / Calliano / Italy
  • ONDAL / Hünfeld / Germany
  • Optomedical Technologies GmbH / Lübeck / Germany
  • orgaMed Zentrale / LAATZEN / Germany
  • ORGENTEC Diagnostika GmbH / Mainz / Germany
  • Ortho Apply Innovation BV / Gravenhage / The Netherlands
  • Ossacur AG / Oberstenfeld / Germany
  • Otto Bock Healthcare Products GmbH / Wien / Austria
  • PakuMed medical products gmbh / Essen / Germany
  • PARI GmbH / Starnberg / Germany
  • Paul Scherrer Institut / Villigen / Switzerland
  • PB Swiss Tools GmbH / Wasen/Bern / Switzerland
  • pes diagnosesysteme GmbH / Leipzig-Markkleeberg / Germany
  • pfm medical ag / Köln / Germany
  • Pharmacia Production B.V. / Groningen / The Netherlands
  • Pierenkemper GmbH / Ehringshausen / Germany
  • Pius-Hospital Oldenburg / Oldenburg / Germany
  • Positronic Beam Service GmbH / Rellingen / Germany
  • Pulsion Medical Systems SE / Feldkirchen / Germany
  • Qiagen GmbH / Hilden / Germany
  • Qiagen Instruments AG / Hombrechtikon / Switzerland
  • QIAGEN Lake Constance GmbH / Stockach / Germany
  • Q-Kon Unternehmensberatung / Niederfischbach / Germany
  • Quidel Germany GmbH / Kornwestheim / Germany
  • R-Biopharm AG / Darmstadt / Germany
  • Reinecker Reha-Technik GmbH / Alsbach-Hähnlein / Germany
  • RIEMSER Arzneimittel AG / Greifswald-Insel Riems / Germany
  • ROI Computer AG / Roding / Germany
  • Rontis Hellas SA / Larissa / Greece
  • Rudolf Buck GmbH / Mühlheim an der Donau / Germany
  • Rudolf Riester GmbH / Jungingen / Germany
  • Salvia Lifetec GmbH & Co. KG / Kronberg / Germany
  • SanguiBioTech GmbH / Witten / Germany
  • Sanofi-Aventis Deutschland GmbH / Frankfurt / Germany
  • Sartorius AG / Göttingen / Germany
  • Schaerer Medical AG / Münsingen / Switzerland
  • Schering AG / Berlin / Germany
  • Schmitz & Söhne GmbH & Co. KG / Bönen / Germany
  • Seleon GmbH / Heilbronn / Germany
  • Sensovation AG / Radolfzell / Germany
  • sfm medical devices GmbH / Wächtersbach / Germany
  • Siemens Healthcare Diagnostics Products GmbH / Schwalbach / Germany
  • Sigma Dental Systems-Emasdi GmbH / Handewitt / Germany
  • Sigmund Lindner GmbH / Warmensteinach / Germany
  • SIS Surgical Instrument Systems Ltd. / Port / Switzerland
  • SKF Actuation System (Liestal) AG / Liestal / Switzerland
  • Smith & Nephew Orthopaedics GmbH / Tuttlingen / Germany
  • Somatex Medical Technologies GmbH / Teltow / Germany
  • SOPRO-COMEG GmbH / Tuttlingen / Germany
  • Storz Endoskop Produktions GmbH / Schaffhausen / Switzerland
  • Storz Medical AG / Tägerwilen / Switzerland
  • Stuckenbrock Medizintechnik GmbH / Tuttlingen / Germany
  • Swandale Holdings Pty. Ltd. / Straubenhardt / Germany
  • Tcoag Deutschland GmbH / Lemgo / Germany
  • Tcoag Ireland Ltd. / Bray / Ireland
  • Technische Unternehmensberatung / Schwerte / Germany
  • TECO Medical Instruments GmbH / Neufahrn N.B. / Germany
  • Thomas Recording GmbH / Gießen-Europaviertel / Germany
  • Transasia Biomedicals Ltd. / Mumbai / India
  • TRUMPF Medizin Systeme GmbH + Co. KG / Saalfeld / Germany
  • TÜV SÜD Industrie Service GmbH / Leipzig / Germany
  • U.T.E. Srl / Trento / Italy
  • ulrich medical GmbH & Co. KG / Ulm / Germany
  • Unisensor AG / Attikon / Switzerland
  • Universität Leipzig / Leipzig / Germany
  • Uromedica, Inc. / Plymouth / USA
  • URS Universal Robot Systems / Schwerin / Germany
  • V. Krütten / Idstein / Germany
  • VAMED-KMB GmbH / Warenübernahme - Bauteil 33 / Wien / Austria
  • Varian Medical Systems Haan GmbH / Haan / Germany
  • VascoMed GmbH / Binzen / Germany
  • VEGA Grieshaber KG / Schiltach / Germany
  • Vestfold Audio AS / Sandefjord / Norway
  • Victronic Technology Corporation / Xindian District, 23145 New Taipei City / Taiwan
  • Vital Base AS / Hareid / Norway
  • Vitasystems GmbH / Mannheim / Germany
  • Vivonic GmbH / Sailauf / Germany
  • Völker AG / Hainichen / Germany
  • V-ZUG AG / Zug / Switzerland
  • W & H Dentalwerk Bürmoos GmbH / Bürmoos / Austria
  • Waldemar Link GmbH & Co / Hamburg / Germany
  • Westsächsische Hochschule Zwickau / Zwickau / 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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