Peter Roka

QUAREGIA GmbH - Quality & Regulatory Compliance

Qualitymanagement and Regulatory Affairs Services for Medical Devices, Medical Device Software, In Vitro Diagonstic Devices and Combination Products. Cybersecurity Quality Management and Regulatory Affairs. Safety and (Cyber) Security Risk Management, Software Safety and Cybersecurity, Data Protection, E2E Software Lifecycle Process (IEC 62304), Computer System Validation (CSV), Documentation and Submission of Medical Device Software. Usability Engineering and Management, Interdisciplinary Project Management, Remediation Project Management, Product Lifecycle Management, Software- and Hardware Lifecycle Management, Requirements Engineering and Management, Configuration and Change Management, CAPA Management, Manufacturing Process (Production) Management, Platform Engineering and Management, Waste Management