Device Project Manager
Flemming has worked as a project manager in the regulated Medical Device industry for more than 30 years. He communicates seamlessly across all organizational levels and excels at balancing budgets, processes, regulatory compliance, and engineering deliverables—with deep execution expertise in Planning, Software Compliance, Cybersecurity, Traceability, and Verification.
QA/RA Manager & Specialist
More than 20 years of experience in the Medical Device industry spanning Design Control/Product Development, Risk Management, Regulatory & Quality Assurance, LEAN manufacturing, Project Management, Internal/External Audits, R&D-to-production transfer, Clinical Investigations, and GDPR.
Known for pragmatic regulatory and quality solutions across both retail and OEM medical devices and strong cross-functional leadership.
QA Manager/Specialist
With 30+ years in the Medical Device field, Michael knows what it takes to develop and approve complex medical devices while combining quality, safety, and regulatory compliance with an effective and efficient engineering process. Expert in product classification, process optimization, Safety Risk Management, Cybersecurity, Requirements, and Systems Engineering.
