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Qualitäts Management & CE-Zertifizierung

Markteintrittssupport

Deutsches IVD StartUp

INDUSTRIE    Gesundheitswesen

EXPERTISE    Qualitätsmanagement

STANDORT      Deutschland

  • ABOUT
    Financial consolidation to support the strategic transformation and digitalization of the Helmholtz Research Center to ensure a balanced and future-oriented cost structure Role as external interim manager with an established cross-functional project team consisting of both internal and external members Project duration on site >24 months
  • OBJECTIVES
    Financial consolidation of the Helmholtz Center to ensure a sustainable and economically viable revenue and expenditure structure Development and implementation of a holistic consolidation concept in connection with the five-year medium-term and financial planning as well as the overall strategic scientific reorientation of the Helmholtz Research Center Identification, quantification and implementation of optimization measures as a joint initiative of science and administration Efficient controlling, budgeting and quality management processes in cooperation with the finance department Best administrative support of scientific excellence by establishing new organizational structures and processes in administration
  • CHALLENGES
    Consolidation concept design and implementation in the context of a publicly owned research center following cameralistic budgeting and accounting principles Stakeholder management between the administrative and scientific community to ensure an overall successful transformation in the best interest of the center Project management and reporting structure with > 200 single projects and initiatives across various administrative and scientific research disciplines

Professionelle Erfahrung

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Solide QM/RA-Kenntnisse, starke biomedizintechnische Kenntnisse, Erfahrung auf dem IVD-Markt 

Wertschöpfung

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Erreichen der IVD-CE-Zulassung

Stakeholder Management

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Starker Umgang mit den Erwartungen des Managements, zwischen normativen, regulativen und operativen Stellen erforderlich

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„Der Markt für In-Vitro-Diagnostika (IVD) ist stark reguliert. Die Erfüllung der jeweiligen regulatorischen Anforderungen ist eine große Belastung für kleine und mittlere Unternehmen (KMU). Die Unterstützung durch externe Experten und der gemeinsame Aufbau der notwendigen Strukturen wie Qualitätsmanagement, technische Dokumentation oder Marktüberwachung beschleunigen den Zeitplan für die CE-Registrierung deutlich.“ 

- Frank Roth, Direktor, MedTech & Life Sciences -

Kontaktieren Sie uns

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Frank Roth

Direktor

  • LinkedIn

Weitere Cases

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Helmholtz Zentrum

Transformation & Reorganization

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MedTech Company

Business Development

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