Brian K. McCollum
Principal Consultant | MBA, CQE, CBA, RAC
brian@gsdmeddevice.com
Principal consultant Brian McCollum has spent more than twenty-five years in medical device design assurance, quality engineering and regulatory affairs, executing design controls on development programs, running quality systems, and auditing both.
His credentials cover the design and statistical rigor behind efficacy, the auditing discipline behind safety, and the supplier and operations experience behind availability.
One consultant, accountable end to end, who has sat through the FDA inspections and Notified Body audits your team is preparing for.
One consultant, who has been successful in all areas of medical device development, who can help you take your product from idea to commercialization.
Experience & Expertise
At GSD, Brian supports clients with:
Regulatory affairs: FDA submissions, notified body management, and EU MDD/MDR strategy.
Quality systems: building and maintaining quality systems to ISO 13485 and 21 CFR 820, across design assurance, operations quality and supplier quality.
Design assurance and product development: design controls, biocompatibility, sterilization validation and quality engineering, with project management from concept through clinical studies.
Risk management: ISO 14971 risk management programs, including FMEA.
Background: Before GSD, Brian led quality and regulatory functions at medical device companies from start-up through acquisition, including Vice President of Quality at Boston Scientific (Apama Medical), Vice President of Quality and Regulatory at BioCardia, Director of Quality on Boston Scientific's TAVR program, and quality and regulatory leadership at Apneon, Avantec Vascular and Cardima. He has supported Class III cardiovascular products from first-in-man through PMA and is a named inventor on four U.S. patents. He began his career in quality and operations at Ford Motor Company. Brian holds an MBA in Finance from Saint Mary's College of California and a BS in Aeronautical Engineering from Embry-Riddle Aeronautical University. He is an ASQ Certified Quality Engineer and Certified Biomedical Auditor, and holds the RAPS Regulatory Affairs Certificate in Medical Devices.
Contact
I'm always looking for new and exciting opportunities. Let's connect.
650-222-5021