With this acquisition, Tentamus strengthens its offerings to assist customers in navigating the complex regulatory landscape, ensuring compliance with cardiovascular device regulations alongside their established testing capabilities with BDC Laboratories. CardioMed’s specialized services include regulatory consulting, pre-clinical consulting, and strategic guidance, positioning Tentamus as a one-stop solution for customers developing innovative cardiovascular and other medical devices.
Dr. Semih Oktay, President of CardioMed Device Consultants, LLC, expressed his excitement about the partnership: "We are thrilled to join the Tentamus Group, a global leader in quality assurance. This collaboration allows us to leverage Tentamus’ international network and expertise while continuing to provide the specialized consulting services our clients rely on. Together, we are better equipped to support cardiovascular device industry globally, from the earliest stages of product development through the regulatory approvals and beyond."
Semih Oktay will continue to lead CardioMed and drive its development, ensuring that the company remains at the forefront of regulatory consulting and pre-clinical services for medical devices. Under his leadership, CardioMed will strengthen its service offering while benefiting from Tentamus’ global resources and infrastructure.
Dr. Christian Rebhan, CEO of Tentamus Group, commented on the strategic value of the acquisition: "The addition of CardioMed’s regulatory and pre-clinical consulting services significantly enhances our offering in the medical device space, particularly for cardiovascular devices. Our clients can now benefit from an even broader service range provided within the Tentamus network and we are delighted to welcome Semih and the CardioMed team to the Tentamus family."
This acquisition marks another milestone in Tentamus’ commitment to expanding its global service capabilities in highly regulated markets. CardioMed Device Consultants, LLC will continue to operate under its current leadership, ensuring continuity for its clients while benefiting from Tentamus’ global network.
About CardioMed Device Consultants, LLC
Cardiomed Device Consultants, LLC is a U.S.-based consulting firm specializing in regulatory and pre-clinical consulting services for cardiovascular and other medical device manufacturers. In addition to cardiovascular devices, CardioMed provides regulatory consulting services for a wide range of medical devices, including orthopedic, neurological, dental and in vitro diagnostic devices. With extensive experience in helping medical device companies navigate complex regulatory environments, CardioMed has become a trusted partner for product development and compliance strategies across various device categories.
Tentamus Group GmbH
An der Industriebahn 26
13088 Berlin
Telefon: +49 (30) 206038-230
Telefax: +49 (30) 206038-190
http://www.tentamus.com
Office Manager, CardioMed Device Consultants, LLC
Telefon: +1 (410) 674-2060
E-Mail: strotter@cardiomedllc.com