David Plescia is a Principal Consultant specializing in medical devices, bringing over 25 years of extensive experience in the medical device and pharmaceutical industries. His current role as a Subject Matter Expert positions him at the forefront of combination product development, where he leverages his...
David Plescia is a Principal Consultant specializing in medical devices, bringing over 25 years of extensive experience in the medical device and pharmaceutical industries. His current role as a Subject Matter Expert positions him at the forefront of combination product development, where he leverages his deep expertise in verification, validation, and manufacturing processes. David’s proficiency in statistical analysis and design of experiments allows him to derive actionable insights from complex performance and manufacturing data, ensuring that products not only meet regulatory standards but also exceed market expectations.
Throughout his career, David has successfully led key projects that involve the intricate lifecycle management of combination products, navigating the challenges of design control and quality systems. His hands-on approach to root cause investigation, particularly in the context of CT imaging, has proven invaluable in addressing critical issues and implementing effective corrective and preventive actions (CAPA). Additionally, David’s skills in test method design and qualification, combined with his knowledge of non-linear, hyperelastic finite element analysis (FEA), enable him to optimize product designs for manufacturability and performance.
David is committed to advancing the field of biomedical engineering through innovative solutions and strategic guidance. His comprehensive understanding of ISO 13485 standards and regulatory compliance further enhances his ability to support organizations in achieving their development goals while maintaining the highest quality standards. As a trusted advisor, David Plescia continues to make significant contributions to the medical device industry, driving progress and fostering excellence in combination product development.
