About Us
Who We Are
At AYM Consulting Services LLC, we specialize in providing regulatory support for medical device companies navigating the FDA’s Unique Device Identification (UDI) requirements.
With years of experience in compliance, quality systems, and GUDID management, we help ensure that your products meet all UDI obligations — quickly, accurately, and stress-free.
Our Mission
To simplify regulatory processes so manufacturers can focus on innovation and patient safety.
Our Vision
To become the leading UDI compliance partner for small and mid-sized medical device companies in the U.S. and Latin America.
About Ytziel Ordosgoite
Founder & Regulatory Consultant – AYM Consulting Services LLC
Ytziel Ordosgoite is an Agricultural Engineer with a specialization in Agro-Industrial processes. She brings over 20 years of experience in Quality and Regulatory Affairs across the Latin American market, having worked in global industries such as Food (Heinz), Consumer Goods (S.C. Johnson), and Medical Devices (Ecleris).
For the past 7+ years, she has focused exclusively on the medical device industry, where she has successfully led compliance strategies, implemented ISO 13485 quality systems, passed multiple ISO 9001 audits, and managed FDA inspections with full compliance.
Currently, Ytziel leads UDI (Unique Device Identification) compliance efforts for medical devices, with a proven 100% success rate in GUDID submissions to the FDA. Her broad regulatory expertise, hands-on leadership, and deep understanding of both global and U.S. compliance requirements make her a trusted advisor for companies entering or expanding in the U.S. medical device market.
