News Updates

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  • Global Business Development Center Announced mdi Consultants Inc.
    to anchor turnkey solution  for companies building U.S. presence
    Read the Press Release

  • mdi's Alan Schwartz at press conference with the El Salvador Minister of Economy
    To learn more about the mdi Consultants, Inc.
    Seminar in El Salvador
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  • mdi Consultants Inc. and LOK-RUS
    are pleased to announce strategic alliance!
    Click here for details

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    Information Database
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  • Alan P. Schwartz, Executive VP, mdi Consultants, Inc. has been invited to join the Editorial Advisory Board of MDT (Medical Device Technology)
    Click here for details


Strategic Alliance

mdi Consultants, Inc. and 
Operon Strategist (India)
Strategic Alliance





Interactive FDA Training Courses

- Understanding QSR
- Intro to Design Control
- Understanding CAPA
For a Quick DEMO

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Contact mdiConsulatnts, Inc.

mdiConsultants, Inc.
55 Northern Blvd
Great Neck, NY 11021

General Information: 1-516-482-9001
FAX:  1-516-482-0186
Click here to
contact us

FDA Consulting


FDA Quality Systems
FDA Regulatory Compliance
FDA Clinical Services to the Medical Device,  Pharmaceutical and Food industries

mdi Consultants Inc. is the leading provider of quality assurance, regulatory compliance, FDA Consulting, and clinical services to the healthcare industry including the Medical Device, Pharmaceutical and Food industries.  mdi Consultants, Inc., is a Medical Device Consulting, U.S. Agent, CE mark, ISO, Pharmaceutical  and Quality Assurance, Regulatory Consulting company and Authorized Agent. 

Since 1978 mdiConsultants have been providing clients high-quality and high-value consulting services such as:
  • FDA Compliance: regulatory strategy development, clinical trial development/ management, cGMP compliance, on-site audits, validation (process, software and sterilization) and 510(k)/PMA/ANDA/NDA submission services 510(k) submission assistance Services
  • FDA Consulting for all aspects of Medical Device, Pharmaceutical, and Food Industries 
  • FDA Trouble Shooting Services
  • 483 & Warning Letter Responses Services
  • Quality System Compliance Services
  • CE Mark Consulting
  • ISO compliance – ISO 9001:2008, ISO 14000, ISO 13485:2012, ISO 14155 and Quality Systems, ISO Consulting.
  • FDA Regulatory Compliance Consulting / EU Consulting
  • U.S. Agent Services
  • Authorized Agent Services
  • Import Agent Services
  • European compliance – CE mark, Medical Device Directive (MDD), In-Vitro Diagnostic Directive (IVDD), and Active Implantable Medical Device Directive (AIMDD)
  • Electronic drug listing and registration, FDA drug listing and registration, electronic listing and registration
  • Health Canada compliance – medical device licensing, establishment licensing, private label licensing, label review, quality system ISO 13485 certification by CMDCAS recognized registrars 
  • Other industry-related services including HACCP, In-Vitro Diagnostic Research and Development, U.S. Agent (for non-U.S. companies), sales force performance improvement, and marketing assistance
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
  • Successfully prepared and submitted over a 1800 510(k) applications
  • Earned a 100% success rate in first time ISO certification
  • Successfully assisted obtaining CE mark  for over 1000 products (Type IIa or above)
  • Worked closely with CMDCAS on obtaining Canadian License for Class II and III medical device

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This is wonderful news. To get the FIRST FDA 510(K) clearance for a Blood Pressure Monitor with a claim “To Be Used by Pregnant women to monitor for the very serious condition of Pre-Eclampsia” is outstanding....... Again, mdi Consultants has done a great job..... 

“[mdi] working with the FDA reviewers was able to save us $1,000’s in retesting dollars and even further delays....."

Drew Queen
Regulatory Affairs Specialist
Fukuda Densh

To see all testimonials, Click Here

“I wouldn’t think of experiencing an FDA audit without MDI’s assistance....."

XiChang Li
Vamed Medical Instrument Co. Ltd.

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“I deeply appreciate the outstanding service that you and MDI have provided our Company over the last 10 years. Your thorough knowledge......"

Chip Garber
J&J Engineering

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To view VIDEO testimonials, Click Here