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mdi Consultants, Inc.

The Global Regulatory Experts Medical Device Compliance Leaders

55 Northern Boulevard
Great Neck, NY 11021-4058

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www.mdiconsultants.com

About mdi Consultants, Inc.

MDI Consultants, with over 45 years of expertise, is a premier provider of FDA regulatory compliance consulting, specializing in medical device, pharmaceutical, and food industry sectors. Our comprehensive services support global companies in achieving and maintaining FDA, EU, and Health Canada compliance, with a proven track record in navigating complex regulatory landscapes. We excel in clinical trial development, cGMP compliance, on-site audits, and the submission of 510(k), PMA, and ANDA applications. Our seasoned team ensures that your products meet stringent regulatory standards, enabling swift market entry and sustained compliance. Partner with MDI Consultants to leverage our deep industry knowledge and commitment to regulatory excellence.

Products by mdi Consultants, Inc.

By mdi Consultants, Inc.

US Designated Agent Services

The FDA requires the use of a U.S. Agent to the Food and Drug Administration for all companies and manufacturers that do not have a presence in the United States. A U.S. Agent to The Food and Drug Administration (FDA) must be a resident of the United States, or have a physical place of business... Read more »

Product Website

By mdi Consultants, Inc.

FDA Compliance for Medical Devices Companies

Our FDA compliance service line enables you to get your products to market quickly and to maintain your FDA compliance status. As professional consultants to the healthcare industry for over 3 decades, mdi has helped hundreds of companies to achieve and maintain their FDA compliance. What are... Read more »

Product Website

By mdi Consultants, Inc.

ISO Compliance and ISO Standards

ISO is a set of global quality standards that are geared to companies providing products or services as a framework for achieving customer satisfaction through implementing a quality management system. The ISO set of standards have become an important mechanism to allow companies to inform their... Read more »

Product Website

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Clients of mdi Consultants, Inc.

  • EEG Spectrum International
  • Rex Medical
  • Premier Heart, Inc.
  • QLT, Inc.
  • Globus Medical
  • MicroLIfe, USA
  • Panasonic Corp
  • Reichert Corp
  • Pride Mobility

Upcoming Events featuring mdi Consultants, Inc.

  • MD&M South (Booth #Charlotte,)
    June 4, 2025 through June 06, 2025