Abe Mathews currently serves as the Vice President of Regulatory Affairs and Quality Assurance at Coherex Medical Inc., a pioneering startup in the medical device sector based in Utah. With a robust background in the medical device industry, including a distinguished career at Johnson &...
Abe Mathews currently serves as the Vice President of Regulatory Affairs and Quality Assurance at Coherex Medical Inc., a pioneering startup in the medical device sector based in Utah. With a robust background in the medical device industry, including a distinguished career at Johnson & Johnson, Abe brings a wealth of experience and expertise to his role. His transition from Boston Scientific to Coherex Medical reflects his commitment to innovation and excellence in healthcare technology.
At Coherex Medical, Abe is instrumental in leading key projects that focus on the development and commercialization of cutting-edge medical devices. His deep understanding of design control processes ensures that products not only meet regulatory requirements but also adhere to the highest standards of quality assurance. Abe’s proficiency in CE marking and ISO standards, particularly ISO 9000, is vital in navigating the complex landscape of global regulatory compliance, enabling the company to expand its market reach effectively.
Abe's expertise extends into clinical development and hardware diagnostics, where he leverages his Six Sigma training to enhance operational efficiencies and drive continuous improvement. His strategic vision and leadership are pivotal in fostering a culture of quality and compliance within the organization, ensuring that Coherex Medical remains at the forefront of innovation in drug delivery systems and medical devices. As he continues to shape the future of healthcare technology, Abe Mathews exemplifies the blend of regulatory acumen and quality assurance that is essential for success in today’s dynamic medical device industry.
