PROVIDING WORLD CLASS SERVICES
PRIMARILY IN THE MEDICAL DEVICE, COSMETIC PRODUCTS,
PERSONAL LUBRICANT, NUTRACEUTICAL / DIETARY SUPPLEMENT FIELDS
Medical Device Establishment Registration & Listing with US FDA
FDA Registration - FDA Agent - FDA Certification
We support your company’s needs for the FDA Quality Assurance and Regulatory systems,
MDSAP Audit program, EU market, IVDR, CE mark preparation, 510(k) submissions, and ISO Quality system preparation for certification.
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 ON-GOING BASIS.
US FDA 510(k) Consulting for Medical Devices, MDSAP Audit Preparation, new European Medical Device Regulation (MDR) and IVDR, management consulting
FDA submissions done faster, done smarter.
Full-service regulatory consultancy. Our proven processes deliver your projects and submissions faster and at a lower cost
IS A REGULATORY CONSULTANCY ORGANIZATION AND LEADING PROVIDER IN U.S. FDA AND INTERNATIONAL QUALITY AND REGULATORY AFFAIRS COMPLIANCE PROGRAMS WITH WORLD-CLASS SERVICE PRIMARILY IN THE MEDICAL DEVICE, COSMETIC, PERSONAL LUBRICANT, AND NUTRACEUTICAL/DIETARY SUPPLEMENTS.
WE HELP COMPANIES’ OPEN DOORS TO ALL IMPORTANT MARKETS OF THE WORLD. MED-DEVICE CONSULTING INC.’S STRATEGY SERVES BUSINESSES THROUGHOUT THE WORLD INCLUDING EUROPE, AUSTRALIA, CANADA, SOUTH AMERICA, CHINA, AND JAPAN.
WE CAN HELP YOU WITH OVER 30 YEARS EXPERIENCE…
HOW WE WORK
Med-Device Consulting, Inc. works closely with you and your manufacturing team. From our years of experience in the business, we have developed methodologies and processes to help ease the transition from "the way it has always been" to the way it must be to meet quality and regulatory requirements.
We work collaboratively with your team from the initial analysis to the final result. Unlike other consultants, Med-Device Consulting, Inc. won't simply leave you with a list of items to fix. Instead, we:
Work with your team to discover the root cause (if appropriate);
Develop a solution that is compatible with your manufacturing environment;
Implement the solution;
And train your team so that they can manage the process going forward.