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
mdi leverages a proven and tested methodology with seasoned
and experienced consultants.
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.