Expert Medical Device Consulting

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.

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.

REGULATORY SUPPORT 

We aims to help your business succeed by streamlining the regulatory process. Our experienced regulatory consulting and compliance team commands an unparalleled breadth and depth of knowledge of US and European regulatory frameworks and can work with you to achieve your business objectives. Drawing on our deep scientific knowledge, our regulatory team develops and executes detailed strategies for your product, providing a clear path through all critical milestones to achieve a successful outcome, whether for a submission or a meeting. We also support post-authorization regulatory operations, including product launch and publications review. We maintain your product's regulatory status throughout its lifecycle. Our track record of success in both the US and Europe is unmatched. As the only genuine global consultancy, our chemists and regulators have helped hundreds of small and large firms move their products from one regulatory hurdle to the next. We work collaboratively with your team from the initial analysis through the final 510(k) submission, when necessary, achieving positive results.

Med-Device Consulting is a leading force in Personal Lubricant Regulatory Services Consulting within the industry. As a top-tier consulting powerhouse for personal lubricants, we are unwavering in our commitment to quality and regulatory compliance. Our expert team is dedicated to delivering comprehensive guidance and facilitating 510(k) submissions for a diverse range of personal lubricants, including both water-based and silicone-based formulations. Each submission is crafted with precision, reflecting our extensive knowledge and dedication to meeting the highest FDA regulatory standards.

Established in 1999, Med-Device Consulting boasts years of unrivaled experience across an extensive array of products, from traditional personal lubricants to flavored options, heated massage lotions, toy cleaners, arousal serums, skincare solutions, and aromatic heating massage oils.

Located strategically in Los Angeles, California, we focus on creating exceptional 510(k) submissions for intimate and sexual wellness products. Additionally, we excel in supporting manufacturing formulation in personal lubricants, providing expert guidance for filling, developing vaginal suppositories, and addressing a variety of cosmetic and healthcare needs. 

Whether you aim to develop your own branded line of lubricants or want to utilize your unique formulation and ingredients, Med-Device Consulting is your definitive partner in transforming your vision into reality.