“Under Fran’s leadership, IRADIMED gained regulatory approvals in the U.S., Europe and many other countries for the world’s only non-magnetic MRI compatible infusion pump and patient vital signs monitor. On behalf of the Board of Directors and everyone at IRADIMED, I would like to congratulate Fran on his retirement and thank him for originating and guiding our regulatory function, providing many key contributions to the success of the company,” said McDonnell. “Steve is a deeply experienced regulatory and quality executive in the medical technology industry. I am confident he will continue to build a world-class regulatory and quality system to support our rapid growth. We are excited to add him to the executive team.”
Kachelmeyer has extensive experience in the medical technology industry. Prior to his appointment at IRADIMED, Kachelmeyer spent more than three years at Merz North America Inc. as its executive director of Regulatory and Quality Affairs. Prior to that, Kachelmeyer was employed at GE Healthcare for 30 years where he spent over 15 years in regulatory and quality roles of increasing responsibility, eventually departing as a Regulatory and Quality executive focused on clinical affairs. He is experienced in all phases of new product registrations and maintaining compliance with the U.S. Food and Drug Administration and other international regulatory bodies. Kachelmeyer has also participated in industry groups responsible for developing international product standards.
Kachelmeyer earned a bachelor’s degree in engineering, technology and electronic technology from DeVry Institute of Technology and an MBA from the Keller Graduate School of Management.