Your Advisory Board

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Beth Brooks
Health Economics & Reimbursement
Joe Hage
Nancy Knettell
62304 and Software Regulatory Compliance
Tom KraMer
Design Engineering
Doug Limbach
Intellectual Property
Robert Packard
Gary Saner
Unique Device Identification (UDI)
Dave Sheppard
Medical M&A Advisory
Michael Sperduti
Medical Device Sales

Rob Packard is a 20-year medical device veteran who manages the 7,500+ member community QA/RA SubGroup and runs a QA/RA consultancy Medical Device Academy. He completed 100+ ISO 13485 certification audits for BSI, and now he specializes in preparing Class III Regulatory Submissions for clients.

Robert Packard, QA/RA

Rob Packard (bio) can help you with questions regarding your:

  • FDA inspections & ISO 13485 certification
  • CE marking & Canadian device licensing
  • Continuing education / quality training
  • CAPA & root cause analysis
  • Supplier quality management & supplier auditing
  • Adverse event reporting & recalls
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