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Med-Device Consultingm-dci.usMED-DEVICE CONSULTING provides specialized regulatory, quality, and lifecycle support for medical devices, cosmetics, personal lubricants, and nutraceuticals, helping clients navigate US and European regulatory requirements. Our services include FDA 510(k) submissions, MDSAP, MDR/EU compliance, ISO 13485:2016 QMS development, risk assessment, Part 11/210/211/820 compliance, labeling, and post-authorization support. With 30+ years of experience as a global regulatory consultancy, we assist with FDA registrations, US agent services, CE marking, UDI submissions, and ongoing regulatory operations to ensure uninterrupted product shipments.
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