Medical technology is fascinating...It is interdisciplinary, promising, provides scientific challenges, and generates - from manufacturer and user up to patient - socio-economic and technological opportunities.And it holds just as many challenges. This makes medical technologies so exciting to my team and myself.Through my 17 years of project experiences in the development of medical devices, I learned systematically to balance opportunities and risks against each other and I also learned how to lead and motivate teams. My technical understanding, knowledge of design control, regulatory requirements and Quality Management Systems as well my empathy ability enables a structured approach and guides the way to success.But the key ingredients for success are confidence, persistence and - finally - the passion for "the" project.
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Ceo And FounderVive-Medconsult UgBochum, Nrw, De
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Programmanager Preclinical ImagingBruker Biospin Jan 2024 - PresentEttlingen, Baden-Württemberg, Deutschland -
Ceo / FounderVive-Medconsult Ug Apr 2020 - PresentDeutschland
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FounderVive-Medtech Gmbh Sep 2019 - PresentDeutschland -
Validationexpert IolCarl Zeiss Meditec Ag May 2023 - Feb 2024Berlin, Deutschland -
Head Of Research And Development / Member Of The Global Leadership TeamHeidelberg Engineering Jun 2020 - Apr 2023Deutschland -
Project Manager Mdr Technical FileLinde Jun 2019 - Apr 2020Metropolregion MünchenUpdate of Technical Files (STED, MDR) / Clinical Evaluation / Verification /Usability / Risk Management -
Expert Quality Management Mdr / Mdsap / En Iso 13485Carl Zeiss Vision International Gmbh Oct 2019 - Jan 2020Aalen, Baden-WürttembergUpdate of Quality Management System regarding MDR (Regulation 2017/745) and MDSAP / Trainings -
Project Manager Regulatory Affairs Medical DevicesGetinge Sep 2014 - May 2019HechingenProject Manager Regulatory Affairs / Recertification / Remediation of Class 3Medical Devices / Preparing Technical Files (STED) / Shelf-Life Studies / Trainings -
Expert Quality Management En Iso 13485:2016Fresenius Medical Care Nov 2017 - Jun 2018Schweinfurt (Stadt), BayernExpert Regulatory Affairs / Analysis of Quality Management Systemaccording to possible risks related to FDA requirements. -
Cto / Co-FounderHapticom Ug Jan 2013 - Dec 2017Dresden / MünchenDevelopment of communication systems for deaf-blind people including:▪ Quality Management System (EN ISO 13485 / 21 CFR Part 820)▪ Usability / Clinical Evaluation (MedDev 2.7.1)▪ Riskmanagement /FMEA (EN ISO 14971)▪ Technical Documentation / Design Dossier (DHF, DMR)▪ Projectmanagement/Coordination
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Project Lead Design Control / Risk Management Acc. Iso 14971 / Qm-System Acc. Iso 13485Keller Medical Gmbh Jul 2015 - Dec 2016Bad Soden Am Taunus, HessenEstablishing of a QM-System according ISO 13485:2016 with focus on designcontrol and risk management
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Project Lead Medical Devices: Focus Organ PerfusionBundesministerium Für Wirtschaft Und Energie / Www.Organ-Lifetool.Net Sep 2013 - Mar 2016BochumDevelopment of Perfusionsystems (CE-Class 3) including:▪ Design and Development Planning▪ Quality Management Systems (EN ISO 13485 / 21 CFR Part 820)▪ Riskmanagement / FMEA (EN ISO 14971)▪ Technical Documentation / Design Dossier (DHF, DMR)▪ Regulatory Affairs/ Certification (CE, FDA)▪ Patent Strategies▪ Projectmanagement / Coordination -
Expert Validation And Technical File (Sted)Biofrontera Group Mar 2015 - Aug 2015Leverkusen, Nordrhein-Westfalen -
Expert Mdd Technical File / CertificationPulsion Medical Systems Se Nov 2014 - Feb 2015Metropolregion MünchenGap Analysis of several technical files / Defining strategic approaches -
University Lecturer In Biomedical EngineeringFachhochschule Köln Mar 2008 - Aug 2014KölnLectures, Seminars and Workshops to MPG, development of medical devices, quality and risk management acc. ISO 14971 as well as design control strategies, Quality Management Systems (ISO 13485) and medical device industry in general.
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Ceo / Cto / FounderIlias-Medical Gmbh Dec 2007 - Oct 2012BochumDevelopment of mobile heart-lung machines including:▪ Development of hardware and disposables (Class 2b) for the CE-Market▪ Organisation and installation of a complete clean room production▪ Leading 16 employees▪ Establishing a complete QMS (EN ISO 13485)▪ Riskmanagement (EN ISO 14971)▪ Planning of international regulatory strategies▪ Communication with notified bodies and BfArM▪ Planning and execution of internal and supplier audits▪ Organization of the… Show more Development of mobile heart-lung machines including:▪ Development of hardware and disposables (Class 2b) for the CE-Market▪ Organisation and installation of a complete clean room production▪ Leading 16 employees▪ Establishing a complete QMS (EN ISO 13485)▪ Riskmanagement (EN ISO 14971)▪ Planning of international regulatory strategies▪ Communication with notified bodies and BfArM▪ Planning and execution of internal and supplier audits▪ Organization of the patent system, planning, strategy, applications▪ Performing numerous in vitro and in vivo studies▪ Technical Documentation / Design Dossier (STED, DHF, DMR) Show less
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Team Leader At The Department Of Engineering / Exist Founder Scholarship Of BmwiRheinische Fachhochschule Köln May 2007 - May 2008KölnDevelopment of mobile heart-lung-machines (class 2b)▪ Technical Documentation / Design Dossier▪ Regulatory Affairs / Submission Strategies▪ Planning and structuring of business models▪ Stakeholder identification▪ Site analysis and investor acquisition -
Project Manager For Applied Medical EngineeringRwth Aachen University 2003 - Feb 2007AachenDevelopment of oxygenators and centrifugal pumps (class 2a and 2b)▪ Calculation, Simulation and Design of Medical Devices▪ Performing numerous in vitro and in vivo studies▪ Technical Documentation / Design Dossier (DHF) -
Software Developper And ConsultantThl-Consulting Jan 2001 - Dec 2002WürselenPlanning and implementation of software projects
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Studentische HilfskraftFev Europe Gmbh Jun 1996 - Mar 1998AachenValidation of control valves on the engine test bench -
Studentische HilfskraftRwth Aachen University, Metal Forming Institute Oct 1992 - Mar 1996AachenSimulation of rolling processes using FEM (finite element method)
Andreas Strauß Education Details
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Mba, Business Strategy, Entrepreneurship, Innovation, Transformation -
Diplomarbeit: 1,3 Diplom: Gut
Frequently Asked Questions about Andreas Strauß
What company does Andreas Strauß work for?
Andreas Strauß works for Vive-Medconsult Ug
What is Andreas Strauß's role at the current company?
Andreas Strauß's current role is CEO and Founder.
What schools did Andreas Strauß attend?
Andreas Strauß attended Thepower Business School, Rheinisch-Westfälische Technische Hochschule Aachen / Rwth Aachen.
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Andreas Strauß
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Andreas Strauss
Andreas Strauss Business Consulting, Managing DirectorGreater Munich Metropolitan Area -
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