Mdi Consultants, Inc.
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, Inc.
Not specified in the provided content.
Services
Regulatory strategy, premarket submission support and compliance services for medical device manufacturers targeting US, EU and Canadian markets.
Regulatory consulting for pharmaceutical and biologics sponsors covering submission strategy, compliance and lifecycle management including biosimilars/follow-on biologic considerations.
Compliance support for food and dietary supplement companies including HACCP implementation, label review, facility registration and FSMA guidance.
Designated U.S. agent and official correspondent services for foreign manufacturers required to maintain a U.S. regulatory contact.
Guidance through EU conformity assessment and technical documentation preparation for CE marking under applicable regulations.
Support for ISO quality management implementation and preparation for MDSAP audits and first-time ISO certification.
Regulatory strategy, premarket submission support and compliance services for medical device manufacturers targeting US, EU and Canadian markets.
Regulatory consulting for pharmaceutical and biologics sponsors covering submission strategy, compliance and lifecycle management including biosimilars/follow-on biologic considerations.
Compliance support for food and dietary supplement companies including HACCP implementation, label review, facility registration and FSMA guidance.
Designated U.S. agent and official correspondent services for foreign manufacturers required to maintain a U.S. regulatory contact.
Guidance through EU conformity assessment and technical documentation preparation for CE marking under applicable regulations.
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
News & Updates
CST Technologies, Inc. has been a longtime client of MDI, and we’re proud to have played a role in helping them reach this milestone. CST Technologies: Engineering the Future of Diagnostics Life Sciences Review. Over four decades, CST has specialized in reshaping diagnostics.
FDA proposes requirements for minor dosage form changes to OTC monograph drugs. FDA issued Proposed Administrative Order OTC000038.
FDA released draft guidance on validating diagnostic tests for emerging pathogens during public health emergencies.
First-time ISO Certification Success Rate
Achieved a 100% success rate in first-time ISO certification for clients.
510(k) Application Submissions
Successfully prepared and submitted over 1800 510(k) applications.
CE Mark Approvals
Assisted over 1000 products in obtaining CE mark approval.
CST Technologies, Inc. has been a longtime client of MDI, and we’re proud to have played a role in helping them reach this milestone. CST Technologies: Engineering the Future of Diagnostics Life Sciences Review. Over four decades, CST has specialized in reshaping diagnostics.
FDA proposes requirements for minor dosage form changes to OTC monograph drugs. FDA issued Proposed Administrative Order OTC000038.
FDA released draft guidance on validating diagnostic tests for emerging pathogens during public health emergencies.
First-time ISO Certification Success Rate
Achieved a 100% success rate in first-time ISO certification for clients.
510(k) Application Submissions
Successfully prepared and submitted over 1800 510(k) applications.
CE Mark Approvals
Assisted over 1000 products in obtaining CE mark approval.