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
Products
Expert Witness Services
Independent, objective expert analysis and testimony in FDA-regulated medical products with strengths in technical product evaluation, failure analysis, root cause investigations, and regulatory compliance assessment.
FDA Regulatory & Expert Witness Services
Consulting and expert witness services provided by Alan Donald, MS, MBA, RAC, FRAPS, with over four decades of experience in FDA-regulated medical products including medical devices, diagnostics, pharmaceuticals, biologics, and combination products.
Expert Witness Services – Alan Donald, MS, MBA, RAC, FRAPS
Expert witness services specializing in FDA medical devices, biologics, pharmaceuticals, diagnostics, software medical devices (AI/ML), and combination products with extensive experience in Federal and State court cases.
Integrated Scientific & FDA Regulatory Expert Witness
Objective scientific and FDA regulatory analysis for complex litigation and product development involving FDA-regulated products.
Expert Witness Services
Independent, objective expert analysis and testimony in FDA-regulated medical products with strengths in technical product evaluation, failure analysis, root cause investigations, and regulatory compliance assessment.
FDA Regulatory & Expert Witness Services
Consulting and expert witness services provided by Alan Donald, MS, MBA, RAC, FRAPS, with over four decades of experience in FDA-regulated medical products including medical devices, diagnostics, pharmaceuticals, biologics, and combination products.
Expert Witness Services – Alan Donald, MS, MBA, RAC, FRAPS
Expert witness services specializing in FDA medical devices, biologics, pharmaceuticals, diagnostics, software medical devices (AI/ML), and combination products with extensive experience in Federal and State court cases.
Integrated Scientific & FDA Regulatory Expert Witness
Objective scientific and FDA regulatory analysis for complex litigation and product development involving FDA-regulated products.
Services
Customized regulatory strategy development, preparation and management of regulatory submissions and pre-submission interactions (IDE, PMA, 510(k), BLA, HUD/HDE).
QMS implementation and remediation, inspection preparation, onsite inspection support and inspection recovery.
Protocol design and development, medical monitoring, study monitoring, investigator recruitment, multinational trial management, investigator brochure and CRF development.
Biostatistical design, methodology development, analysis and reporting plus clinical data collection, integration, database management and specialized reporting (including multilingual review).
Management of regulatory agency interactions, meeting preparation and presentations to support submissions and regulatory decision-making.
Advisory support for start-up and small companies with reduced fee structures and guidance on US market entry via pre-submission engagement.
Customized regulatory strategy development, preparation and management of regulatory submissions and pre-submission interactions (IDE, PMA, 510(k), BLA, HUD/HDE).
QMS implementation and remediation, inspection preparation, onsite inspection support and inspection recovery.
Protocol design and development, medical monitoring, study monitoring, investigator recruitment, multinational trial management, investigator brochure and CRF development.
Biostatistical design, methodology development, analysis and reporting plus clinical data collection, integration, database management and specialized reporting (including multilingual review).
Management of regulatory agency interactions, meeting preparation and presentations to support submissions and regulatory decision-making.
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