Tessa Yamut serves as the Head of Clinical and Regulatory Affairs for Endovascular Robotics at Siemens Healthineers, where she plays a pivotal role in shaping the future of medical technology. With over 20 years of experience in the medical device industry, Tessa is adept at...
Tessa Yamut serves as the Head of Clinical and Regulatory Affairs for Endovascular Robotics at Siemens Healthineers, where she plays a pivotal role in shaping the future of medical technology. With over 20 years of experience in the medical device industry, Tessa is adept at navigating the complexities of regulatory frameworks and clinical pathways, ensuring that innovative devices are not only compliant but also effectively meet market needs. Her expertise in EU Medical Device Regulation and FDA Breakthrough Device Designation has been instrumental in accelerating the introduction of novel endovascular robotic solutions in both the US and international markets.
In her current role, Tessa leads the development of global clinical and regulatory strategies, focusing on the integration of Software as a Medical Device (SaMD) into endovascular robotics. Her hands-on approach allows her to de-risk regulatory and reimbursement programs by formulating creative strategies that streamline regulatory submissions, including 510(k)s and other essential product launch activities. Tessa's commitment to quality assurance and adherence to regulatory guidelines ensures that Siemens Healthineers maintains its reputation for excellence in the medical device sector.
Key projects under her leadership include the advancement of cutting-edge robotic systems designed to enhance surgical precision and patient outcomes. By fostering collaboration across multidisciplinary teams, Tessa not only drives innovation but also cultivates a culture of compliance and accountability. Her strategic vision and ability to navigate regulatory landscapes make her an invaluable asset to Siemens Healthineers, as the company continues to lead the way in transforming healthcare through advanced technology.
