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Quality Management & CE-certification

Going to Market Support

German IVD StartUp

 INDUSTRY    Healthcare

 EXPERTISE   Quality Management

 LOCATION      Germany

Professional Experience

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

Value Creation

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Achieving IVD CE- registration

Stakeholder Management

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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 -

Contact Us

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Frank Roth

Principal

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