MedRes - Medical Research Engineering
Stephanie Fossat-Dominguez is an accomplished professional with extensive experience in quality management and operations within the medical device and biomaterials industries. Currently serving as the Director of Quality at MedRes - Medical Research Engineering since June 2024, Stephanie emphasizes continuous improvement and cross-functional team leadership. Prior to this role, Stephanie was the Vice President of Operations and Quality at ALTA Biomaterials, overseeing multiple operational facets during the transition from CeloNova. Stephanie's career includes significant positions at CeloNova BioSciences, Inc., where responsibilities ranged from leading manufacturing and distribution to managing quality systems, as well as supporting important regulatory submissions. Stephanie's earlier roles include leading quality engineering efforts at Abbott Vascular and providing essential quality responses at International Rectifier. Stephanie holds a Master of Science in Engineering in Materials Science from INSA Toulouse and a Diplome d'Etudes Approfondies in the same field from Universite Paul Sabatier.
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MedRes - Medical Research Engineering
MedRes is a medical technology company with 20 years of experience in designing, developing, and manufacturing medical devices. We specialize in complex surgical systems, including minimally invasive handheld devices, fluid management systems, controllers and the software that controls their various functions. We offer a range of services to clients of all sizes including contract manufacturing, contract development, supply chain management, and consulting services in quality assurance, regulatory and clinical affairs. We have extensive experience in various medical specialties like gynecology, urology, cardiology, airway management, gastroenterology, and orthopedics, allowing us to handle their unique challenges and opportunities. We provide high-quality, customized manufacturing solutions for small to high volume production, from component manufacturing to the assembly of finished medical devices. Our production facility includes a Class 8 cleanroom and controlled manufacturing areas. We offer contract development services personalized for each project to guide you through all stages of medical device development. They include ideation, designing, prototyping, testing and transfer to pilot and volume manufacturing. Ensuring quality is our top priority, and our development and manufacturing processes strictly adhere to industry standards such as ISO 13485 and FDA regulations. Our QA team has deep experience in quality system development, design control processes, and regulatory requirements for market approval in the US and EU, with strong connections to clinical and academic centers. We take pride in our multiple medical devices that are currently on the market, and we are proud that many of our successful projects have been integrated into major medical device company portfolios and have gained worldwide recognition.