atHeart Medical announced today that it has commenced operations and is initiating its U.S. Investigational Device Exemption (IDE) trial.
Scott is a veteran regulatory affairs executive with a proven track record in successful global regulatory strategies.
Alex’s broad range of expertise in operations and operations quality results from 30 years in the cardiac and cardiovascular medtech industry.
Alexander is Vice-President of Operations at atHeart Medical since May 2022. He has been with the company in a consulting role since it began operations in 2020.
With a drive for accomplishments and a strong compliance attitude, Alex has a remarkable experience spanning from manufacturing to clinical project management, from sales and business development to quality assurance.
Alex previously worked in-house at major corporations, such as Abbott and Guidant, and at start-up companies such as Xeltis. More recently, he also worked in the medtech industry as a consultant.
Alexander holds a biomedical engineering degree from Technical University Ulm, Germany.
Maureen’s expertise is setting up quality systems for successful start-up organizations.
Maureen is Vice-President of Quality for atHeart Medical since April 2022. She joined the company, bringing over twenty years of distinguished quality experience in multiple, prominent cardiovascular medical device start-ups such as Twelve and Ardian.
She has previously worked both in-house and as a consultant for a number of medical device companies that have been acquired by major medical device corporations, including Medtronic.
A biomedical engineer graduate from Marquette University in Milwaukee, WI, Maureen contributed to the development of intellectual property for systems and methods related to prosthetic heart valve devices.
In her spare time, she is also a Court Appointed Special Advocate (CASA) – volunteering to enrich the lives of kids in foster care.
Laurent is a global medtech executive with talent for turning research projects into commercially viable companies.