Dr. Holger Ernst

Dr. Holger Ernst Email and Phone Number

Physicist PhD, Managing Director bei Ernst Invent @
Dr. Holger Ernst's Location
Constance, Baden-Württemberg, Germany, Germany
About Dr. Holger Ernst

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;

Dr. Holger Ernst's Current Company Details
Ernst Invent

Ernst Invent

Physicist PhD, Managing Director bei Ernst Invent
Dr. Holger Ernst Work Experience Details
  • Ernst Invent
    Physicist Phd, Managing Director
    Ernst Invent Jan 2010 - Present
    Konstanz Und Umgebung, Deutschland
    Multiple Projects in the field of Development and Consulting - see Business Spectrum above in the summary- see Project description below under item "Projekte"
  • Klarlite Gmbh
    Cto
    Klarlite Gmbh Jul 2009 - Dec 2009
    Konstanz Und Umgebung, Deutschland
  • Elexxion Ag
    Head Of R&D
    Elexxion Ag Oct 2004 - Jun 2009
    Konstanz Und Umgebung, Deutschland
    Management 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.
  • Laser Zentrum Hannover E.V.
    Scientific Assistant
    Laser Zentrum Hannover E.V. Feb 2001 - Sep 2004
    Hannover Und Umgebung, Deutschland
    Multiple R&D projects in the field of medical laser systems.

Dr. Holger Ernst Skills

Project Management Product Development Regulatory Affairs Quality Assurance R&d Product R&d Medical Device R&d Physics Laser Laser Physics Optics Optical Engineering Medical Devices Medical Device Directive Class Iii Medical Devices Fda English German Consulting Technical Documentation Quality Management Forschung Und Entwicklung Arzneimittelzulassung Produktentwicklung Medizinprodukte Projektmanagement Validation Englisch Physik

Dr. Holger Ernst Education Details

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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