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ABOUT

 

About GSD

WHY GSD

 

Fifty plus combined years on the manufacturer's side of the table.

 

 

GSD is a boutique consulting company providing Design Assurance, Regulatory Affairs and Quality System consulting for companies in the medical device development and manufacturing industry, including regulatory guidance, quality systems development, internal auditing, and document control.

TEAM

 

The people behind GSD

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Brian McCollum

Principal Consultant

  • Certified Quality Engineer (ASQ)

  • Certified Biomedical Auditor (ASQ)

  • Certified Medical Device Auditor (ASQ)

  • Certified Regulatory Affairs Professional

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Eva Chang

Principal Consultant​

  • RAC-US and RAC-Devices (RAPS)

  • Certified Biomedical Auditor (ASQ)

  • Certified ISO 13485:2016 Lead Auditor

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Stephanie McCollum

Consultant​

  • Certified Quality Auditor (ASQ)

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© 2026 by GSD Medical Device Consulting. 

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