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Quality Management & CE-certification

Going to Market Support

German IVD StartUp

 INDUSTRY    Healthcare

 EXPERTISE   Quality Management

 LOCATION      Germany

    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
    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
    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

Professional Experience


Solid QM/RA expertise, strong biomedical engineering skills, IVD market experience 

Value Creation


Achieving IVD CE- registration

Stakeholder Management


Strong handling of management expectations required in between normative, regulative and operational bodies

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„The In-Vitro Diagnostics (IVD) market is strongly regulated. The fulfillment of the respective regulatory requirements is a heavy burden for Small and Medium sized Enterprises (SME). Getting support from external experts, and jointly setting-up the necessary structures like quality management, technical documentation or market surveillance, is clearly accelerating the timeline for CE registration. “ 

- Frank Roth, Principal, MedTech & Life Sciences -

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Frank Roth


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