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

· FDA EUA, 510 (k), Drug registration for Disinfectants

· US Agent Services and Official Correspondent for Foreign Companies

· MDSAP (Medical Device Single Audit Program) – implementation and preparation

· 510(k)/PMA/ANDA/NDA/DMF/IDE Planning - Preparation and Submission

· FDA compliance – Regulatory strategy development, Pre-Sub, 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.