Trusted Partner Network
About Our Expertise
Our Mission
Led by founder Louie Goryoka, Med-Device Consulting Inc. (M-DCI) boasts over 30 years of expertise in regulatory compliance, quality assurance, and market strategies for medical devices. We specialize in navigating complex FDA, ISO, and international standards, ensuring your products meet rigorous requirements for success.
Meet Our Experts
Our expert team has over 30 years of experience guiding clients through regulatory pathways. We provide comprehensive services in FDA submissions, ISO compliance, risk assessments, and market strategy, ensuring your medical devices meet international standards and achieve market success.
Our Expert Services
Our Core Offerings
Leverage our expertise in U.S. and EU medical device compliance. Our team provides tailored strategies in quality assurance, regulatory affairs, and market entry to safeguard your products and ensure smooth operations.
Prepare for GMP Certification and meet global regulatory standards with our comprehensive training in FDA regulations, ISO standards, and technical documentation for CE and FDA approvals.
Achieve full compliance with FDA and international standards through audits, risk assessments, and tailored training in GMP, QSR, and design control for medical devices.
Strengthen supplier relations, handle FDA 483s, and manage recalls with our compliance and remediation expertise.