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Some of Lori's experience includes:

  • 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
  • Previous Adjunct Professor of Regulatory Affairs at Colorado State University (Fort Collins, CO) for 21 CFR 820 and ISO 13485:2003
  • 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
  • Remediated FDA Warning Letters
  • Conducted 21 CFR 820 Certification Audits

Copyright © 2019 Lori A. Carr / All rights reserved.