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:
Assist in FDA regulatory strategies – Pre-Sub, 513(g) and 510(K)s
· US Agent Services and Official Correspondent for Foreign Companies
. FDA EUA and conversion to 510 (k)s, Drug registration for Disinfectants
· 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)
. Assisting with “Breakthrough” Designation and working with AI devices
. Assisting with FDA inspections – prior to and during the FDA inspection
· FDA Troubleshooting and CRISIS INTERVENTION - Response to 483 and Warning letters – FDA mitigation
· 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.