About Us
Who We Are
At AYM Consulting Services LLC, we help medical device and food companies navigate complex regulatory requirements, implement effective quality systems, and achieve compliance with confidence.
Founded with a strong background in medical device regulatory affairs, AYM has expanded its expertise to support organizations throughout their compliance journey—from FDA registrations and UDI implementation to ISO 13485 Quality Management Systems, FDA QMSR readiness, internal audits, and global regulatory requirements.
Our food compliance services assist manufacturers, importers, and distributors in meeting FDA requirements through Food Facility Registration, FSVP programs, supplier qualification, labeling compliance, and food safety readiness.
We believe compliance should be practical, efficient, and aligned with business objectives. Our approach combines regulatory knowledge with real-world industry experience to provide solutions that support both compliance and sustainable growth.
Whether you are entering the U.S. market, preparing for an audit, implementing a quality management system, or strengthening your regulatory processes, AYM Consulting Services is committed to being your trusted compliance partner.
Our Areas of Expertise
- ISO 13485 Implementation & Quality Systems
- FDA QMSR Readiness
- Internal Audits & Gap Assessments
- FDA Registration & Device Listing
- UDI / GUDID Compliance
- Food Facility Registration
- FSVP Programs
- Food Labeling Compliance
- Supplier Qualification & Food Safety Readiness
- SQF Certification
Our Mission
To help medical device and food companies navigate regulatory requirements, implement effective quality systems, and achieve compliance with confidence, enabling them to bring safe and compliant products to market.
Our Vision
To become a leading quality and regulatory consulting firm in the Americas, helping organizations strengthen compliance, improve quality, and expand access to global markets through expert guidance and innovative solutions.
About Ytziel Ordosgoite
Ytziel Ordosgoite is an Agricultural Engineer specializing in Agro-Industrial Processes, with more than 20 years of experience in Quality, Regulatory Affairs, and Compliance across highly regulated industries.
Throughout her career, she has held quality and regulatory leadership roles in multinational organizations, including the food, consumer goods, and medical device sectors, working with globally recognized companies.
Over the past several years, Ytziel has focused extensively on the medical device industry, supporting organizations in the implementation and maintenance of Quality Management Systems, regulatory compliance programs, and market access strategies. Her experience includes ISO 13485 implementation, FDA QMSR readiness, internal audits, CAPA programs, risk management, FDA registrations, UDI/GUDID submissions, and global regulatory requirements.
She has successfully supported organizations through FDA inspections, quality system improvements, and regulatory compliance initiatives, helping companies strengthen their operations while maintaining compliance with applicable regulations and industry standards.
In addition to medical devices, Ytziel provides consulting services to food manufacturers, importers, and distributors seeking to comply with FDA requirements, including Food Facility Registration, FSVP programs, supplier qualification, labeling compliance, and food safety readiness.
Through AYM Consulting Services LLC, she is committed to helping organizations build practical quality systems, achieve regulatory compliance, and successfully access the U.S. and international markets.
Quality Systems | FDA Compliance | ISO 13485 | FDA QMSR | Medical Devices | Food Compliance
✅ 20+ Years in Quality & Regulatory Affairs | ✅ FDA Inspection Experience | ✅ ISO 13485 & QMSR Implementation Support | ✅ Medical Devices & Food Compliance Expertise