"Her tremendous depth of experience will help with our design and management of clinical trials and regulatory aspects as Establishment Labs takes Motiva implants from the PMA process to commercialization in the United States.”
New York, NY (PRWEB) May 23, 2016
Establishment Labs, a global medical device company focused on breast implant technologies with a strong emphasis on product development and innovation, is pleased to announce that Kristine (“Kris”) Foss has joined the company as Global Vice President of Regulatory and Clinical, principally to oversee the company's clinical and regulatory pathway to the U.S. market.
"We are fortunate to have recruited someone with Kris' history, reputation and capability for this key role," said Juan José Chacón Quirós, CEO of Establishment Labs. "Her tremendous depth of experience will help with our design and management of clinical trials and regulatory aspects as Establishment Labs takes Motiva Implants® from the PMA process to commercialization in the United States."
Kris Foss holds a Bachelor’s degree from Northwestern University and Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professional Society (RAPS). She has more than 25 years of experience in global clinical and regulatory management of complex medical devices and has a particularly relevant background in the aesthetics industry that includes PMA approval of the first Mentor (Johnson & Johnson) silicone gel breast implant.
"Kris offers a broad range of regulatory and clinical experience from nearly 25 years in the medical device industry. I cannot think of anyone more qualified to pave the way for the US approval of our next generation breast implant technology," said Dr. Allan Weinstein, Board Member at Establishment Labs.
"Motiva implants can significantly improve the lives of millions of patients, and I look forward to taking them through US trials and into the market." stated Kris, "I am excited to help Establishment Labs become the global leader in safety and positive patient outcomes."
About Establishment Labs:
Establishment Labs is a global, privately held, breast implant and medical technology company that designs, develops, manufactures and markets an innovative product portfolio consisting of advanced silicone-filled breast and body shaping implants (http://www.motivaimplants.com). Utilizing only the highest quality of medical grade silicones, the CE-marked Motiva Implants® line is rigorously scrutinized by professional Quality Engineers throughout the entire manufacturing process. All of its products are manufactured in full compliance with ISO and EU requirements, and are certified under the Medical Device Directive 93/42/EEC.