Meet the Expert
With over fifteen years in MedTech, I've learned that sometimes the hardest thing to do is understand what is being asked of manufacturers. I specialize in breaking down those regulatory requirements into simple terms and providing practical tools and methods to meet them. With a focus on usability and safety, I help teams navigate the complexities of international standards through a lean, expert-driven approach to product development.
Background & Experience
Regulatory Proficiency: Extensive experience in FDA QSR, EU MDR, ISO 13485, ISO 62366 and IEC 60601-1-6 compliance for high-risk medical devices.
Project Diversity: Supporting surgical hardware, complex data visualization, and software-as-a-medical-device (SaMD) platforms.
Human Factors: Leading formative evaluations that translate user and clinical feedback into definitive engineering and safety specifications, and validations to provide evidence of safety for submission.
How I Work
My methodology is anchored in lean principles and engineering robustness. By eliminating unnecessary overhead and focusing on critical usability paths, I provide a clear, user-centered framework for regulatory success. I make the effort to learn how you work, to integrate directly with your engineering and quality teams and ensure compliance fuels innovation rather than hindering it.