Expert Medical Device Consulting mdci@m-dci.us
specialize in regulatory compliance, providing support for FDA submissions for medical devices, and personal lubricants
OUR MISSION
Our Mission
“His deep understanding of the personal lubricant and vaginal suppository regulatory landscape gave me complete confidence, and I always felt we were in good hands. He’s highly responsive, operates with integrity, and consistently finds effective solutions when challenges arise.
Louie played a key role in securing FDA 510(k) clearance. His experience working with the FDA and familiarity with the CDRH review process clearly contributed to a smooth and successful outcome. I’d highly recommend him to anyone looking for a trusted and knowledgeable regulatory partner.”
At MED-DEVICE CONSULTING, we provide expert medical device consulting to guide you through FDA submissions, ISO standards, and European regulations for medical devices. Our dedicated team ensures that your products, including Personal Lubricants with FDA 510(k) submissions and Vaginal Suppositories with FDA 510(k) submissions, meet all necessary compliance requirements efficiently and accurately.
We specialize in a variety of areas, including medical devices, cosmetic products, personal lubricants, and nutraceuticals.
THE MISSION OF MED-DEVICE CONSULTING, INC. IS TO ASSIST COMPANIES IN MEETING THEIR STRATEGIC OBJECTIVES BY PROVIDING HIGHLY SPECIALIZED EXPERTISE AND ASSISTANCE ON A PROJECT, TEMPORARY, OR ONGOING BASIS.
Our US FDA 510(k) submissions are designed to ensure that Personal Lubricants are handled efficiently and intelligently, enabling faster, smarter FDA submissions.
About Our Expertise
Our SERVICE
At MED-DEVICE CONSULTING, we provide expert medical device consulting to guide you through FDA submissions, ISO standards, and European regulations for medical devices. Our dedicated team ensures that your products, including Personal Lubricants with FDA 510(k) submissions and Vaginal Suppositories with FDA 510(k) submissions, meet all necessary compliance requirements efficiently and accurately.
We specialize in a variety of areas, including medical devices, cosmetic products, personal lubricants, and nutraceuticals.
THE MISSION OF MED-DEVICE CONSULTING, INC. IS TO ASSIST COMPANIES IN MEETING THEIR STRATEGIC OBJECTIVES BY PROVIDING HIGHLY SPECIALIZED EXPERTISE AND ASSISTANCE ON A PROJECT, TEMPORARY, OR ONGOING BASIS.
Our US FDA 510(k) submissions are designed to ensure that Personal Lubricants are handled efficiently and intelligently, enabling faster, smarter FDA submissions.
Meet Our Experts
Our expert team has over 30 years of experience guiding clients through regulatory pathways, specializing in FDA submissions for medical devices. We provide comprehensive medical devices consulting services that include FDA submissions, ISO compliance, risk assessments, and market strategy, ensuring your medical devices meet international standards and achieve market success.
About MED-DEVICE CONSULTING
Medical Device Regulatory Experts
REGULATORY SUPPORT
We aim to help your business succeed by streamlining the regulatory process. Our experienced regulatory consulting and compliance team possesses an unparalleled breadth and depth of knowledge of US and European regulatory frameworks, enabling us to work with you to achieve your business objectives. Leveraging 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, maintaining 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 navigate through regulatory hurdles. We work collaboratively with your team from the initial analysis through the final 510(k) submission, achieving positive results.
Med-Device Consulting is a leading force in Personal Lubricants with FDA 510(k) submissions 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 with an extensive array of products, including traditional personal lubricants, 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 formulations for personal lubricants, providing expert guidance on filling, developing vaginal suppositories, and FDA 510(k) submissions, 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.
Strategic Market Entry Support
We develop customized strategies for market entry in the US and Europe, specifically focusing on FDA submissions for medical devices. This approach reduces approval times and facilitates successful launches, including Personal Lubricants with FDA 510(k) submissions and Vaginal Suppositories FDA 510(k) submissions. Our team is dedicated to helping you expand your global footprint.
Quality Management Consulting
Our expert team has over 30 years of experience guiding clients through quality and regulatory pathways, specializing in FDA compliance programs and medical device submissions.
We provide comprehensive medical device consulting services, including FDA submissions, ISO compliance, risk assessments, and market strategy, ensuring your medical devices meet international standards and achieve market success.
REGULATORY SUPPORT
Med-Device Consulting is a leading force in Personal Lubricants with FDA 510(k) submissions 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.
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. We aim to help your business succeed by streamlining the regulatory process.
Our experienced regulatory consulting and compliance team possesses an unparalleled breadth and depth of knowledge of US and European regulatory frameworks, enabling us to work with you to achieve your business objectives. Leveraging 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, maintaining 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 navigate through regulatory hurdles. We work collaboratively with your team from the initial analysis through the final 510(k) submission, achieving positive results.
About MED-DEVICE CONSULTING
Expert Regulatory Guidance
Comprehensive Quality Systems
Comprehensive Quality Systems
At MED-DEVICE CONSULTING, we provide expert medical devices consulting to guide you through FDA submissions, ISO standards, and European regulations for medical devices. Our dedicated team ensures that your products, including Personal Lubricants with FDA 510(k) submissions and Vaginal Suppositories FDA 510(k) submissions, meet all necess
At MED-DEVICE CONSULTING, we provide expert medical devices consulting to guide you through FDA submissions, ISO standards, and European regulations for medical devices. Our dedicated team ensures that your products, including Personal Lubricants with FDA 510(k) submissions and Vaginal Suppositories FDA 510(k) submissions, meet all necessary compliance requirements efficiently and accurately.
We specialize in a variety of areas including medical devices, cosmetic products, personal lubricants, and nutraceuticals.
THE MISSION OF MED-DEVICE CONSULTING, INC. IS TO ASSIST COMPANIES IN MEETING THEIR STRATEGIC OBJECTIVES BY PROVIDING HIGHLY SPECIALIZED EXPERTISE AND ASSISTANCE ON A PROJECT, TEMPORARY, OR ONGOING BASIS.
Our US FDA 510(k) submissions are designed to ensure that Personal Lubricants are handled with efficiency and intelligence, allowing for faster and smarter FDA submissions.
Comprehensive Quality Systems
Comprehensive Quality Systems
Comprehensive Quality Systems
Our expert team has over 30 years of experience guiding clients through regulatory pathways, specializing in FDA submissions for medical devices. We provide comprehensive medical device consulting services, including FDA submissions, ISO compliance, risk assessments, and market strategy, ensuring your medical devices meet international st
Our expert team has over 30 years of experience guiding clients through regulatory pathways, specializing in FDA submissions for medical devices. We provide comprehensive medical device consulting services, including FDA submissions, ISO compliance, risk assessments, and market strategy, ensuring your medical devices meet international standards and achieve market success.
REGULATORY SUPPORT
We aim to help your business succeed by streamlining the regulatory process. Our experienced regulatory consulting and compliance team possesses an unparalleled breadth and depth of knowledge of US and European regulatory frameworks, enabling us to work with you to achieve your business objectives. Leveraging 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, maintaining 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 navigate through regulatory hurdles. We work collaboratively with your team from the initial analysis through the final 510(k) submission, achieving positive results.
Global Market Access
Comprehensive Quality Systems
Global Market Access
We develop customized strategies for market entry in the US and Europe, with a focuswith on FDA submissions for medical devices. This approach reduces approval times and facilitates successful launches, including Personal Lubricants with FDA 510(k) submissions and Vaginal Suppositories FDA 510(k) submissions. Our team is dedicated to helping you expand your global footprint.
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, including guidance on FDA submissions for medical devices. Our program covers ISO standards and technical documentation essential for CE and FDA approvals, specifically tailored for products like Personal Lubricants with FDA 510(k) submissions and Vaginal Suppositories FDA 510(k) submissions.
Achieve full compliance with FDA submissions and international standards through audits, risk assessments, and tailored training in GMP, QSR, and design control for medical devices consulting, including Personal Lubricants with FDA 510(k) submissions and Vaginal Suppositories FDA 510(k) submissions.
Strengthen supplier relations, handle FDA 483s, and manage recalls with our compliance and remediation expertise, including guidance on FDA submissions for medical devices. We specialize in Personal Lubricants with FDA 510(k) submissions and provide support for Vaginal Suppositories FDA 510(k) submissions.
Expert Medical Consulting
Our Service Offerings
Discover our comprehensive consulting services in regulation, compliance, and product development to elevate your healthcare business.
Upcoming Events
Client Success Stories
Read how we’ve helped clients achieve compliance and market success in the medical device industry.
"I can’t recommend Louie enough. From day one, he treated our FDA clearance project like it was his own—not just bringing great expertise and efficiency, but also a real sense of care and commitment throughout the entire process.
His knowledge of the regulatory space gave me a lot of confidence, and I always felt like we were in good hands. What really stood out to me was his responsiveness, integrity, and willingness to roll up his sleeves and figure things out when challenges arose.
He was a huge part of us successfully getting our FDA 510(k) clearance, and I’d absolutely recommend him to anyone looking for someone they can trust to guide them through the regulatory process."
— Dr. Anna Cabeca, DO, FACOG
Founder, Cabeca Health Institute
Client
"His deep understanding of the personal lubricant and vaginal suppository regulatory landscape gave me complete confidence, and I always felt we were in good hands. He’s highly responsive, operates with real integrity, and consistently finds solutions when challenges arise.
Louie played a key role in securing FDA 510(k) clearance, and he knows all the reviewers at CDRH, which helps his credibility. I’d highly recommend him to anyone looking for a trusted and knowledgeable regulatory partner.
Client Success Stories
Read how we’ve helped clients achieve compliance and market success in the medical device industry.
Current Promotions
Take advantage of our current consulting packages designed to boost your regulatory compliance.
Company News
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FAQs for Clients
Frequently Asked Questions
1. What types of FDA submissions do you support?
We support a range of submissions, including 510(k)s, De Novo requests, and regulatory strategy for Class I, II, and select Class III devices, with a focus on women’s health and OTC-related products.
2. What industries or product categories do you specialize in?
We specialize in compliance programs (QA/RA), 510(k) submissions (personal lubricants, vaginal suppositories, and other women’s health products), as well as cosmetics, dietary supplements, and nd consumer medical devices.
3. When should I bring in a regulatory consultant?
The earlier, the better. Getting regulatory input during product development can prevent costly delays and help ensure a smoother path to clearance.
4. How long does the FDA 510(k) process take?
While timelines can vary, most 510(k) reviews take several months. We help streamline the process by ensuring your submission is complete, clear, and aligned with FDA expectations.
5. Do you communicate directly with the FDA?
Yes, we can manage FDA interactions on your behalf, including Pre-Subs, deficiency responses, and overall communication throughout the review process.
6. What makes your approach different?
We combine deep regulatory expertise with a highly responsive, hands-on approach—treating every project as if it were our own and focusing on practical, results-driven solutions.
7. Can you help if we've already started or had issues with a submission?
Absolutely. We frequently step in to troubleshoot ongoing submissions, address FDA feedback, and get projects back on track.
8. What can I expect when working with you?
Clear communication, fast turnaround times, strategic guidance, and a partner who is fully invested in your success from start to finish.
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9. Do you work with companies based outside the United States?
Yes, we regularly support international companies seeking to enter the U.S. market and navigate FDA requirements.
10. Can you act as our U.S. regulatory representative?
We can guide you on U.S. Agent requirements and help coordinate communications to ensure compliance with FDA expectations.
11. How do you help international companies navigate the FDA process?
We translate FDA regulations into clear, actionable steps—helping you understand requirements, avoid common pitfalls, and align your product with U.S. standards.
12. Do you support companies with no prior FDA experience?
Absolutely. We frequently work with first-time FDA submitters and provide end-to-end guidance, from regulatory strategy through submission and clearance.
13. Can you help adapt our existing international regulatory data (e.g., CE marking) for FDA use?
Yes, we assess and optimize existing documentation to align with FDA expectations, reducing duplication of effort wherever possible.
14. How do you handle time zone differences and communication?
We maintain flexible communication and fast response times to ensure seamless collaboration, regardless of location.