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Global Innovation Summit 2026

6 May 2026 | Basel, Switzerland

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Sabine Nieba

COO and Partner / Innosuisse coach

Quaregia GmbH

Kestenholz, Switzerland

3 profile visits

Regulatory affairs and quality management professional with more that 20 years experience in the medical device and IVD industry. Innosuisse coach.

My organisation

Quaregia GmbH

Quaregia GmbH

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Kestenholz, Switzerland

QUAREGIA supports CE Marking, International Product Approvals, Technical Files, Device Safety (Electrical Safety, Mechanical Safety), Risk Management, Usability Engineering, Product Lifecycles, Software- and Hardware Lifecycle Management, Requirements Engineering, Configuration and Change Management, Remediation, CAPA, Manufacturing Process Validation Medical Device Software: Software Safety and Cybersecurity, Artificial Intelligence, Data Protection, Software Lifecycle Process (IEC 62304), Computer System Validation (CSV), Documentation and Submission of Medical Device Software Due Diligence Support (e.g. company take-overs, investments), Project Management
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About me

Regulatory affairs and quality management professional with more that 20 years experience in the medical device and IVD industry.

Innosuisse coach.

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