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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

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

other

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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