Capabilities
Quality Management & CE-certification
Going to Market Support
German IVD StartUp
INDUSTRY Healthcare
EXPERTISE Quality Management
LOCATION Germany
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
„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
Frank Roth
Principal
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