Area of expertise Medical Device Pharma SMEs Audit Management Basic UDI Biological Evaluation Change Management Clinical Compliance Clinical Evaluation Design Control Gap Analysis Injection Moulding ISO 10993 ISO 13485 ISO 9001 Lead Auditor Management MDR Medical Device Engineering Microfluidics Process Validation Product Development Project Management Prototyping QA QMS Qualified Lead Qualified Person Quality Management Quality Management Systems Risk Analysis Risk Assesment Risk Management Six Sigma Testing Strategies Toxicology Traceability UDI Usability Validation Reset filters Toxicology and Biosafety (ID1001) 100,00 kr. QA Expert with experience in regulatory affairs (ID1007) 100,00 kr. Labelling, UDI and Traceability Specialist (ID1011) Senior Consultant Audit and Validation (ID1025) 100,00 kr. Clinical Evaluation and Biosafety (ID1002) 100,00 kr. Senior Clinical Compliance Expert (ID1003) 100,00 kr. Senior QA/RA Expert (ID1004) 100,00 kr. Human Factors Engineering Specialist (ID1010) HW/SW and Semiconductor Specialist (ID1012) Management and change management (ID1016) Senior Consultant Medical Device (ID1018) Validation Specialist, Technology and Chemestry (ID1019)