Business-SpectrumDevelopmentComplete development process, starting with the first product idea up to the start of production, or any customer-defined part of this process. In-house feasibility studies, risk analysis, project management, development on system-level, development of laser or optical components, system documentation, verification and validation on system-level respectively laser or optical components, certification of medical products (CE-Europe & FDA-US) and -after achievement of maturity phase- production cut over. ConsultingCustomized R & D Consulting – the complete development process or parts of it depending on customer requirements, e.g. risk analysis or development of optical systems (see also Development)Consulting in the field of regulatory affairs (CE/MDD, FDA/UL/CSA).Consulting regarding quality assurance according to ISO 9001, ISO 13485, 21CFR820;
Ernst Invent
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Physicist Phd, Managing DirectorErnst Invent Jan 2010 - PresentKonstanz Und Umgebung, DeutschlandMultiple Projects in the field of Development and Consulting - see Business Spectrum above in the summary- see Project description below under item "Projekte"
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CtoKlarlite Gmbh Jul 2009 - Dec 2009Konstanz Und Umgebung, Deutschland
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Head Of R&DElexxion Ag Oct 2004 - Jun 2009Konstanz Und Umgebung, DeutschlandManagement of the complete development process - budget and timeframe responsibility 3x product development projects, as well as 1 design-to-cost project including regulatory affairs with successful CE certificationof class IIb medical devices; especially focus on EN 60601-1-series and EN 60825-12x successful FDA-510(k) certifications of class IIb medical devices taking UL/CSA as well as CDRH-requirement into account.
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Scientific AssistantLaser Zentrum Hannover E.V. Feb 2001 - Sep 2004Hannover Und Umgebung, DeutschlandMultiple R&D projects in the field of medical laser systems.
Dr. Holger Ernst Skills
Dr. Holger Ernst Education Details
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Physik
Frequently Asked Questions about Dr. Holger Ernst
What company does Dr. Holger Ernst work for?
Dr. Holger Ernst works for Ernst Invent
What is Dr. Holger Ernst's role at the current company?
Dr. Holger Ernst's current role is Physicist PhD, Managing Director bei Ernst Invent.
What schools did Dr. Holger Ernst attend?
Dr. Holger Ernst attended Universität Hannover.
What skills is Dr. Holger Ernst known for?
Dr. Holger Ernst has skills like Project Management, Product Development, Regulatory Affairs, Quality Assurance, R&d, Product R&d, Medical Device R&d, Physics, Laser, Laser Physics, Optics, Optical Engineering.
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