mdi Consultants, Inc.

The Global Regulatory Experts Medical Device Compliance Leaders

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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.

Company Details

Editor Verified
Address
55 Northern Boulevard
Great Neck, NY 11021-4058

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News & Press Releases

Press Release

Codes, Codes, and Codes

Published: 2/12/2025
Press Release

FDA Releases Draft Guidance on Pulse Oximeters for Medical Purposes – Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations

Published: 2/9/2025
Press Release

FDA Releases Draft Guidance on Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency

Published: 2/9/2025