Development & DfX
Requirements, design inputs/outputs, risk management, verification/validation, transfer to manufacturing.
About
I help teams move from concept to commercialization with clear strategy, rigorous design controls, and practical execution. My background spans 35+ years across engineering, quality, and business development, with deep experience in high-volume disposables and regulated medical products.
Quality & Compliance
QMS, design controls, supplier quality, 21 CFR 820/ISO 13485 alignment, audit readiness.
Strategy & Growth
Market assessment, product roadmaps, partnerships, due diligence, integration planning.
Contact
Or email me directly: jim@example.com