Matrix Medical Consulting
Matrix Medical Consulting is a comprehensive medical regulatory and clinical affairs consulting company specializing in FDA regulatory sciences, clinical trials, and Quality Systems for medical devices, diagnostics, and combination products. With over 25 years of experience, they assist clients in attaining FDA approval/clearance for innovative products, ensuring Quality System compliance, and achieving development goals. They develop customized regulatory strategies tailored to each company's unique needs.
Industries
Nr. of Employees
small (1-50)
Matrix Medical Consulting
San Diego, California, United States, North America
Services
Regulatory strategy and submissions
Customized regulatory strategy development, preparation and management of regulatory submissions and pre-submission interactions (IDE, PMA, 510(k), BLA, HUD/HDE).
Quality Management Systems (QMS) and inspection support
QMS implementation and remediation, inspection preparation, onsite inspection support and inspection recovery.
Clinical trial services
Protocol design and development, medical monitoring, study monitoring, investigator recruitment, multinational trial management, investigator brochure and CRF development.
Biostatistics and data management
Biostatistical design, methodology development, analysis and reporting plus clinical data collection, integration, database management and specialized reporting (including multilingual review).
Regulatory agency liaison and meeting management
Management of regulatory agency interactions, meeting preparation and presentations to support submissions and regulatory decision-making.
Start-up advisory program
Advisory support for start-up and small companies with reduced fee structures and guidance on US market entry via pre-submission engagement.
Regulatory strategy and submissions
Customized regulatory strategy development, preparation and management of regulatory submissions and pre-submission interactions (IDE, PMA, 510(k), BLA, HUD/HDE).
Quality Management Systems (QMS) and inspection support
QMS implementation and remediation, inspection preparation, onsite inspection support and inspection recovery.
Clinical trial services
Protocol design and development, medical monitoring, study monitoring, investigator recruitment, multinational trial management, investigator brochure and CRF development.
Biostatistics and data management
Biostatistical design, methodology development, analysis and reporting plus clinical data collection, integration, database management and specialized reporting (including multilingual review).
Regulatory agency liaison and meeting management
Management of regulatory agency interactions, meeting preparation and presentations to support submissions and regulatory decision-making.
Start-up advisory program
Advisory support for start-up and small companies with reduced fee structures and guidance on US market entry via pre-submission engagement.
Expertise Areas
- Regulatory strategy and submissions for medical devices and combination products
- Clinical trial design and management
- Quality Management Systems (QMS) and compliance
- Biostatistics and clinical data analysis
Key Technologies
- Software as a medical device (SaMD)
- Artificial intelligence applied to medical devices
- Genomics-related product regulation
- Biostatistical methods for clinical studies