Matthew Asselin

Medical device development and engineering expert with extensive experience designing, developing, and commercializing products in compliance with ISO 13485, IEC 62304, and ISO 14971. I specialize in building robust, regulatory-ready systems that align quality management, software lifecycle processes, and risk management from concept through post-market.

With a deep understanding of medical device design controls, quality systems, and cross-functional engineering leadership, I have successfully guided products through the full development lifecycle—from early feasibility and requirements definition to verification, validation, and regulatory submission. My expertise includes establishing and maintaining ISO 13485–compliant quality management systems, implementing IEC 62304 software development lifecycles, and executing comprehensive risk management strategies aligned with ISO 14971.

I thrive at the intersection of engineering, quality, and regulatory, ensuring products are not only innovative but also safe, effective, and audit-ready. I bring a structured, systems-thinking approach to complex development challenges, enabling teams to deliver high-quality medical technologies efficiently and compliantly.

Core strengths include:
• Medical device product development (Class I–III)
• Design controls & DHF management
• Software lifecycle processes (IEC 62304)
• Risk management & usability engineering (ISO 14971)
• ISO 13485 Quality Management Systems
• Cross-functional technical leadership
• Regulatory strategy & submission support