Specialized expertise to aid companies in delivering exceptional medical device and diagnostic products in a compliant manner
Specialized expertise to aid companies in delivering exceptional medical device and diagnostic products in a compliant manner
Flexibility to work across multiple areas: Project Management, Cross-functional Team Leadership. SW Management, Systems Requirements, SW Quality Assurance, Risk Management, SW/System Lifecycle Management, SW Process Improvement, Agile & Waterfall Methodologies, CAPA Definition & Oversight
Industry experience in multiple management positions delivering products across a wide spectrum: Infusion pumps, Injector systems, X-ray devices, Clinical diagnostics, Chemistry/Immunoassay assay development, Single cell isolation & imaging analysis, Digital cognitive assessment, Laboratory automation
ISO 13485 Quality Systems, IEC 62304 Medical Device Software, FDA, EU MDR, China NMPA regulations
We look forward to discussing how we can assist your company
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