Frequently Asked Questions (FAQs)
Have Questions?
Regulatory compliance can feel complex, especially when working with medical devices or food products. This FAQ section covers key questions about quality systems, FDA readiness, UDI, ISO 13485, and food compliance to help you move forward with confidence.
Medical Device Quality & Regulatory Compliance
AYM supports medical device companies with ISO 13485 implementation, FDA QMSR readiness, internal audits, FDA registration, device listing, UDI/GUDID compliance, and labeling review.
ISO 13485 is the internationally recognized Quality Management System standard for the medical device industry. It helps organizations establish processes for quality, risk management, documentation, traceability, supplier control, CAPA, and regulatory compliance.
Not necessarily. While ISO 13485 is commonly used by manufacturers, it may also apply to contract manufacturers, distributors, service organizations, repair centers, private labelers, and suppliers involved in the medical device lifecycle.
FDA QMSR is the Quality Management System Regulation that aligns FDA quality system requirements more closely with ISO 13485. Medical device establishments should evaluate their quality systems to ensure readiness for FDA expectations.
AYM can support companies through gap assessments, procedure review, internal audits, CAPA review, risk management evaluation, supplier control review, quality agreement assessment, and action plans for compliance improvement.
A Gap Assessment is an evaluation of your current quality or regulatory system against applicable requirements such as ISO 13485, FDA QMSR, FDA regulations, or food compliance standards. The result is a practical action plan to address gaps.
Yes. AYM supports internal audits for ISO 13485, FDA QMSR readiness, medical device compliance, and food compliance programs. Internal audits help identify weaknesses before external audits or inspections.
Medical Device Quality & Regulatory Compliance
Most medical devices marketed in the United States are subject to FDA UDI requirements, although some exceptions may apply depending on device type, class, and regulatory status.
GUDID stands for Global Unique Device Identification Database. It is the FDA database where device labelers submit required UDI-related device information.
The device labeler is responsible for submitting and maintaining accurate UDI information in GUDID.
AYM Consulting Services help medical device companies successfully implement and maintain FDA UDI Compliance. Our services include UDI strategy, Device Identifier (DI) assignment, GUDID submission, labeling reviews, data maintenance, and ongoing regulatory support, allowing your organization to meet FDA requirements efficiently and with confidence.
Food Compliance
AYM supports food manufacturers, importers, and distributors with FDA Food Facility Registration, FSVP programs, supplier qualification, labeling compliance, regulatory assessments, and food safety readiness.
FDA Food Facility Registration is required for many domestic and foreign facilities that manufacture, process, pack, or hold food for consumption in the United States.
FSVP stands for Foreign Supplier Verification Program. It requires U.S. importers to verify that foreign food suppliers are producing food in compliance with applicable FDA food safety standards.
Yes. AYM can review food labels for general FDA compliance, including ingredient statements, nutrition facts, allergen declarations, claims, and required label elements.
Yes. AYM helps food companies understand FDA requirements, prepare registrations, review labels, evaluate supplier obligations, and organize compliance documentation for U.S. market entry.
Working With AYM
AYM works with small and mid-sized companies in the United States and Latin America, including medical device manufacturers, service organizations, distributors, importers, food manufacturers, and companies entering the U.S. market.
Yes. AYM provides consulting support in English and Spanish for clients across the United States and Latin America.
The best starting point is an initial consultation or gap assessment. AYM can evaluate your current situation and recommend the most appropriate next steps based on your products, market, regulatory status, and business goals.
You can contact AYM Consulting Services through the website contact form or by email to discuss your compliance needs and schedule an initial consultation.
Ready to strengthen your compliance program? Schedule a consultation with AYM Consulting Services today.
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Based in Overland Park, Kansas – Serving clients across the U.S. and Latin America