As the President and Principal Consultant at Medical Innovation Technology Operations Consulting LLC, I leverage my extensive background in the medical device regulatory and quality system arena to provide unparalleled support to clients navigating the complexities of FDA regulations. With a Master of Science in...
As the President and Principal Consultant at Medical Innovation Technology Operations Consulting LLC, I leverage my extensive background in the medical device regulatory and quality system arena to provide unparalleled support to clients navigating the complexities of FDA regulations. With a Master of Science in Bioengineering and firsthand experience as a reviewer at the FDA, I possess a unique perspective on the intricacies of regulatory submissions, including 510(k), PMA, and IDE submissions. My tenure in both the Office of Compliance and the Office of Device Evaluation has equipped me with a deep understanding of Quality System Regulations (QSR) and Good Manufacturing Practices (GMP), allowing me to guide clients through the entire product lifecycle—from concept to market entry.
Currently, I specialize in FDA regulatory and quality system reviews, submission writing, and strategic analysis, focusing on innovative projects in the medical device sector, particularly in tissue engineering and cardiovascular devices. My role involves not only assisting with new product development initiatives but also leading remediation projects to address compliance gaps. I pride myself on fostering strong relationships with regulatory agencies, ensuring that my clients are well-prepared for interactions that can significantly impact their product approval timelines.
Key projects I have undertaken include comprehensive quality system audits, corrective and preventive action (CAPA) implementation, and tailored regulatory strategies that align with clients' unique business goals. My commitment to excellence and my ability to translate complex regulatory requirements into actionable insights empower my clients to achieve their objectives efficiently and effectively, ultimately enhancing patient safety and advancing medical innovation.