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mdi Consultants, Inc. is a leader in providing consulting services to the healthcare industry worldwide. We have extensive expertise in helping medical device, pharmaceutical, biotechnology and food companies achieve compliance with U.S., European and Canadian regulations.

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510(K) 510(k) preparation agriculture alcohol baby formula CBD CE Mark clinical trials Cosmetics COVID-19 COVID Diagnostic Test CPT code Cybersecurity Device Approval Dietary Supplements DUNS ESG Health Canada EUA FDA FDA alternate inspections FDA investigation FDA regulation FDA regulatory cases FDA update Food Complaints Food Industry FSMA GMP hand sanitizer IDEs India In Vitro Diagnostic masks Medical Device MedWatch NDC News OTC Drug Fees Post-Warning Letter Recalls Reimbursement SARS-CoV-2 tests UDI VQIP Warning Letter

Post List

Guidance on Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens

Posted on January 16, 2025

Pulse Oximeters for Medical Purposes

Posted on January 13, 2025

BD receives FDA warning letter

Posted on January 2, 2025

OMUFA Facility Fees for FY 2025

Posted on December 6, 2024

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