mdi Consultants, Inc. Internationally Recognized Consulting Company to the MEDICAL DEVICE/IVD/PHARMACEUTICAL INDUSTRIES

mdi Consultants Inc. has the expertise and can provide you exceptional professional aid in the following areas:

• ASSISTING ON COVID-19 PPE devices, IVD TESTs and OTC registration and listing.
  
• FDA EUA, 510 (k), Drug registration for Disinfectants
• FDA REGISTRATION - United States Agent and Official Correspondent for Foreign Companies
• Assistance with MDSAP (Medical Device Single Audit Program)
• 510(k)/PMA/ANDA/NDA/DMF/IDE Planning - Preparation and Submission, device listing and registration
• FDA compliance – Regulatory strategy development, clinical trial development/ management, cGMP compliance, ISO, CE Mark, On-site audits, validation (process, software and sterilization)
• FDA Troubleshooting, Response to 483 and Warning letters
• UDI & GUDID Compliance

With over 200 years of cumulative industry experience on staff, we have delivered the following results: Helped over 500 companies achieve FDA compliance and/or ISO certification with 100% success in first time ISO certification and CE mark for over 1000 products Successfully prepared and submitted over a 3500 510(k) applications.