Andreas Strauß

Experience

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  RWTH Aachen University, Metal Forming Institute

  Oct 1992 - Mar 1996

  Studentische Hilfskraft

  Simulation of rolling processes using FEM (finite element method)

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  FEV Europe GmbH

  Jun 1996 - Mar 1998

  Studentische Hilfskraft

  Validation of control valves on the engine test bench

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  THL-Consulting

  Jan 2001 - Dec 2002

  Software Developper and Consultant

  Planning and implementation of software projects

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  RWTH Aachen University

  Jan 2003 - Feb 2007

  Project Manager for Applied Medical Engineering

  Development 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)

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  Rheinische Fachhochschule Köln

  May 2007 - May 2008

  Team leader at the Department of Engineering / EXIST Founder scholarship of BMWi

  Development 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

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  Ilias-medical GmbH

  Dec 2007 - Oct 2012

  CEO / CTO / Founder

  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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  Fachhochschule Köln

  Mar 2008 - Aug 2014

  University Lecturer in Biomedical Engineering

  Lectures, 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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  Hapticom UG

  Jan 2013 - Dec 2017

  CTO / Co-Founder

  Development 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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  Bundesministerium für Wirtschaft und Energie / www.organ-lifetool.net

  Sept 2013 - Mar 2016

  Project Lead Medical Devices: Focus Organ Perfusion

  Development 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

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  Getinge

  Sept 2014 - May 2019

  Project Manager Regulatory Affairs Medical Devices

  Project Manager Regulatory Affairs / Recertification / Remediation of Class 3Medical Devices / Preparing Technical Files (STED) / Shelf-Life Studies / Trainings

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  PULSION Medical Systems SE

  Nov 2014 - Feb 2015

  Expert MDD Technical File / Certification

  Gap Analysis of several technical files / Defining strategic approaches

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  Biofrontera Group

  Mar 2015 - Aug 2015

  Expert Validation and Technical File (STED)
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  Keller Medical GmbH

  Jul 2015 - Dec 2016

  Project Lead Design Control / Risk Management acc. ISO 14971 / QM-System acc. ISO 13485

  Establishing of a QM-System according ISO 13485:2016 with focus on designcontrol and risk management

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  Fresenius Medical Care

  Nov 2017 - Jun 2018

  Expert Quality Management EN ISO 13485:2016

  Expert Regulatory Affairs / Analysis of Quality Management Systemaccording to possible risks related to FDA requirements.

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  Linde

  Jun 2019 - Apr 2020

  Project Manager MDR Technical File

  Update of Technical Files (STED, MDR) / Clinical Evaluation / Verification /Usability / Risk Management

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  VIVE-MedTech GmbH

  Sept 2019 - now

  Founder
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  Carl Zeiss Vision International GmbH

  Oct 2019 - Jan 2020

  Expert Quality Management MDR / MDSAP / EN ISO 13485

  Update of Quality Management System regarding MDR (Regulation 2017/745) and MDSAP / Trainings

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  VIVE-MedConsult UG

  Apr 2020 - now

  CEO / Founder
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  Heidelberg Engineering

  Jun 2020 - Apr 2023

  Head of Research and Development / Member of the Global Leadership Team
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  Carl Zeiss Meditec AG

  May 2023 - Feb 2024

  Validationexpert IOL
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  Bruker BioSpin

  Jan 2024 - now

  Programmanager Preclinical Imaging