SF
Stephanie Fossat-Dominguez
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Work Experience
May 2014 - Present · 10 years and 7 months
Director Of Quality
Jan 2016 - Present · 8 years and 11 months
Senior Quality Manager
May 2014 - Jan 2016 · 1 years and 8 months
Company Details
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.
Year Founded
2005
Social Media
Linkedin
Industry
Medical Equipment Manufacturing
HQ Location
Albert Flórián út 3/b Budapest, IX., Budapest 1097, HU
Keywords
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