Hi, I'm Sergio
With over a decade of experience in the medical device industry, I bring innovative solutions that bridge the gap between novel technology and medical applications. My expertise lies in medical device product development, quality systems, regulatory compliance, and program management. I offer consulting services that drive the development and success of groundbreaking medical technologies.
Let’s work together to elevate your medical device projects to the next level.
My Expertise
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Program Management
Leading cross-functional teams to deliver complex projects on time, from concept to launch. Whether it's defining the project management process, developing project plans, or managing resources, I ensure successful outcomes.
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Process Optimization
Improving efficiency in R&D, manufacturing, and regulatory workflows. I use data-driven insights to identify bottlenecks and implement solutions that drive operational excellence.
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Regulatory Compliance
Expertise with FDA 510(k) submissions, ISO, and quality management systems. I help companies navigate the regulatory landscape to ensure the safety and efficacy of their products.
How I Can Help
- Simplifying your complex medical device product development: Expertise in developing innovative and cutting-edge medical technologies using a proven systems engineering approach.
- Cross-functional team leadership and program management: Driving successful outcomes through collaborative project management using agile, waterfall, and hybrid methodologies.
- Quality systems (QMS) and regulatory compliance consulting: Ensuring adherence to industry standards and regulatory requirements while meeting your product needs.
- Strategic consulting for startups and scaling companies: Tailored solutions for growing and scaling operations effectively and efficiently.
Let’s Work Together
Looking for an experienced consultant to help you succeed in the medical device industry? Contact me today