Gil Kan

Background

About Gil Kan

I am a medical device professional with extensive hands-on design experience and a deep understanding of regulatory, quality, and manufacturing requirements. With over 15 years of experience, I have successfully guided concept-to-commercialization projects—from early-stage CAD modeling and feasibility analysis to full-scale manufacturing, regulatory compliance, and sustaining engineering. What sets me apart? I bring both technical depth and strategic insight, ensuring that medical devices are not only innovative but also manufacturable, compliant, and scalable. My expertise spans design engineering, risk management, design quality assurance, design transfer, and QMS implementation. Key Differentiators & Expertise: Concept-to-Commercialization Expertise – Hands-on support from initial CAD design, prototyping, and feasibility analysis to full-scale manufacturing and commercialization. Deep Design Ability & DFM (Design for Manufacturing) – Expert in product design optimization for injection molding, CNC machining, extrusion, and high-volume manufacturing. ISO 14971 Risk Management & Design Quality Assurance – Comprehensive hazard analysis, FMEA, usability studies, and risk-based decision-making to ensure patient safety. Design Control & Requirements Management – Structuring design history files (DHF), risk management plans, and regulatory documentation to align with ISO 13485, FDA 21 CFR Part 820, and MDR. Design Verification & Validation (V&V) & Process Validation – Developing and executing test method validation (TMV), gage R&R, mechanical/electrical/software verification, and process validation. Technical Project Lead Services – Managing multidisciplinary engineering projects, coordinating teams across R&D, QA, RA, and manufacturing. Design Transfer & Sustaining Engineering – Leading smooth design transfer, supplier qualification, and sustaining engineering for post-market product improvements. QMS Consulting & EQMS Implementation – Establishing QMS/EQMS from scratch, to level up design control and compliance. I partner with startups, mid-sized companies, and established enterprises to design, develop, and commercialize medical devices that are innovative, manufacturable, and compliant. Whether you're at the early concept stage, optimizing for manufacturing, managing verification testing, or leading design transfer, I provide both technical and strategic expertise to achieve your goals.