Some of Lori’s experience includes:

  • Conducted FDA requested 21 CFR 820 Certification Audits
  • Remediated FDA Warning Letters
  • Mock FDA Medical Device and BIMO Inspections
  • FDA-483, Inspectional observation, response assistance
  • Certified MDSAP (Medical Device Single Audit Program) Audits
  • Certified ISO 13485:2016 Audits
  • EUMDR Audits
  • Quality Management System (QMS) training and assessments
  • Adjunct Professor of Regulatory Affairs at Colorado State University (Fort Collins, CO) for 21 CFR 820 and ISO 13485:2003
  • Senior FDA Medical Device Specialist Investigator
  • FDA Level II Medical Device Certification
  • FDA Medical Device Performance Auditor
  • Trained new FDA Investigators in conducting medical device inspections
  • FDA Foreign Inspection Team Member and conducted PMA preapproval and postmarket inspections
  • Denver and Cincinnati District Medical Device Registration, PMA and 510(k) Monitor
  • Federal Government Leadership Development Graduate – Class of 2005