Qualifications
Alan Donald, MS, MBA, RAC, FRAPS is a multidisciplinary expert with more than four decades of experience in FDA-regulated medical products. His background integrates FDA regulatory affairs, biomedical science, quality systems, product development, manufacturing operations, and medical/scientific analysis across a broad range of healthcare technologies.
Overview
Mr. Donald has served in executive, regulatory, quality, operational, academic, and consulting leadership roles involving medical devices, diagnostics, pharmaceuticals, biologics, tissue-engineered products, combination products, and software-based medical technologies.
His experience spans product development, FDA submissions, clinical studies, quality systems, adverse event investigations, recalls, post-market compliance, and product liability matters.
This multidisciplinary background enables him to evaluate complex issues involving regulatory compliance, product performance, failure analysis, standards of care, risk management, and causation.
Industry Leadership Experience
Prior to founding Matrix Medical Consulting, Mr. Donald held senior management and executive positions with multiple FDA-regulated medical product companies.
These positions included:
01
President and Founder, Matrix Medical Consulting Corporation
02
Director of Regulatory Affairs, Advanced Bioresearch Associates
03
Senior Manager, Quality Assurance, Advanced Tissue Sciences
04
Founder and Vice President of Operations, Tri-Stage, Inc.
05
Director of Operations, Windsor Medical, Inc.
06
Regulatory Affairs, Quality Assurance, and Operations positions with IMED Corporation, Pharmaco, and IVAC Corporation
His responsibilities included regulatory affairs, quality systems, manufacturing operations, product development, complaint investigations, FDA compliance, clinical studies, risk management, and commercialization of FDA-regulated products.
This experience provides practical insight into how manufacturers develop products, manage quality systems, investigate adverse events, respond to regulatory requirements, and address post-market issues.
Academic & Teaching Experience
Mr. Donald served for approximately sixteen years as a professor in the Master’s Degree Program in Regulatory Affairs at San Diego State University.
Courses taught included:
Medical Device Regulations
Advanced Medical Device Regulations
International Medical Regulations
His teaching focused on FDA regulatory requirements, international regulatory systems, quality systems, product development, and regulatory strategy.
Education
Master of Business Administration (MBA), University of California San Diego
Master of Science (MS), Biochemistry and Cell Biology, San Diego State University Graduate School
Bachelor of Arts (BA), Biology/Human Physiology, Claremont McKenna College and Harvard University
Professional Credentials
Regulatory Affairs Certification (RAC)
Fellow, Regulatory Affairs Professionals Society (FRAPS)
Mr. Donald was awarded Fellow status by the Regulatory Affairs Professionals Society in recognition of significant contributions to the regulatory affairs profession.
Scientific Publications, Patents & Presentations
Mr. Donald has authored peer-reviewed scientific publications, holds a United States patent, and has presented nationally and internationally on topics including:
FDA medical device regulation
Artificial intelligence and software medical devices
Regulatory strategy and planning
Clinical development
Quality systems and compliance
Regenerative medicine
He has served as a speaker, panelist, and instructor at professional conferences and industry forums throughout the United States and internationally.
Professional Service
Mr. Donald has served on:
National Institutes of Health (NIH) grant review committees
Regulatory Affairs Professionals Society (RAPS)
BIOCOM public policy and FDA committees
Corporate boards and advisory boards within the medical technology industry
These activities have provided additional perspective on emerging technologies, regulatory policy, innovation, and commercialization.
Expert Witness Experience
Mr. Donald has served as an expert witness in federal and state court matters involving FDA-regulated products.
His expert witness work has included issues involving:
- FDA regulatory compliance
- Product recalls and field actions
- Medical device performance and failure analysis
- Quality systems and manufacturing controls
- Product labeling and warnings
- Adverse event reporting and post-market surveillance
- Regulatory submissions and clearances
- Standards of care
- Product safety and risk management
His multidisciplinary background allows him to evaluate matters involving the intersection of regulatory requirements, engineering performance, and medical/scientific considerations.
Areas of Expertise
- Medical devices (implantable and non-implantable)
- Diagnostics and in vitro diagnostic products
- Combination products
- Pharmaceuticals and biologics
- Cell and tissue-based therapies
- Software medical devices, artificial intelligence, and machine learning
- FDA regulatory submissions (510(k), De Novo, PMA, IND, IDE, EUA)
- Quality systems and FDA inspections
- Product recalls and corrective actions
- Product labeling, warnings, and risk management
- Adverse event reporting and post-market surveillance
- Clinical studies and regulatory strategy
- Expert witness services and litigation support
Ready for Case Evaluation
Full CV, detailed case history, and testimony record available upon request for qualified engagements.
Contact Alan Donald directly at (619) 208-5624 or adonald@matrixmedcorp.com to discuss your matter.