mdi Consultants
mdi Consultants, Inc. is a leading provider of regulatory compliance consulting, FDA consulting for quality assurance, and international medical device compliance, with 45 years of experience serving the medical device, pharmaceutical, and food industries worldwide. They focus on helping companies achieve compliance with U.S., European, and Canadian regulations, offering services such as product review, registration, cGMP compliance, audits, validation, and more. The company actively participates in regulatory development and maintains a team of industry experts, including former FDA officials, ISO assessors, and quality managers. mdi Consultants also provides guidance on innovative manufacturing technologies such as 3D printing of medical devices and biologics regulation, and offers specialized services like applying for CPT codes and navigating FDA warning letters.
Industries
Nr. of Employees
small (1-50)
mdi Consultants
Great Neck, New York, United States, North America
Services
Medical device compliance and registration
Regulatory strategy, premarket submission support and compliance services for medical device manufacturers targeting US, EU and Canadian markets.
Pharmaceutical and biologics regulatory consulting
Regulatory consulting for pharmaceutical and biologics sponsors covering submission strategy, compliance and lifecycle management including biosimilars/follow-on biologic considerations.
Food industry regulatory and HACCP services
Compliance support for food and dietary supplement companies including HACCP implementation, label review, facility registration and FSMA guidance.
US Agent services for FDA compliance
Designated U.S. agent and official correspondent services for foreign manufacturers required to maintain a U.S. regulatory contact.
CE marking and EU conformity assessment support
Guidance through EU conformity assessment and technical documentation preparation for CE marking under applicable regulations.
ISO/MDSAP certification readiness
Support for ISO quality management implementation and preparation for MDSAP audits and first-time ISO certification.
Medical device compliance and registration
Regulatory strategy, premarket submission support and compliance services for medical device manufacturers targeting US, EU and Canadian markets.
Pharmaceutical and biologics regulatory consulting
Regulatory consulting for pharmaceutical and biologics sponsors covering submission strategy, compliance and lifecycle management including biosimilars/follow-on biologic considerations.
Food industry regulatory and HACCP services
Compliance support for food and dietary supplement companies including HACCP implementation, label review, facility registration and FSMA guidance.
US Agent services for FDA compliance
Designated U.S. agent and official correspondent services for foreign manufacturers required to maintain a U.S. regulatory contact.
CE marking and EU conformity assessment support
Guidance through EU conformity assessment and technical documentation preparation for CE marking under applicable regulations.
ISO/MDSAP certification readiness
Support for ISO quality management implementation and preparation for MDSAP audits and first-time ISO certification.
Expertise Areas
- FDA and international medical product regulatory compliance (US/EU/Canada)
- Clinical trial design and clinical study management
- Quality management systems, cGMP and QSR compliance
- CE marking and EU device regulations (MDR/IVDR/AIMDD)
Key Technologies
- Regulatory submission pathways (510(k), PMA, De Novo, NDA/ANDA equivalents)
- Electronic submission templates and portals (eSTAR / CDRH Portal)
- Process and sterilization validation methodologies
- IVD validation and assay validation approaches