My name is Larry Spears, but people call me Larry Spears. Here is my homepage: . I live in United States and work as an at

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Larry Spears - FDA Regulations Expert

Larry Spears

His Previous positions include:

  • FDA/CDRH Office of Compliance and FDA Investigations - 34 years
  • Big 4 Consulting Firm – 3 years

He has the expertise of end to end implementation of medical device processes including creation & implementation of master compliance plans, SOPs, CAPAs, DHFs, complaint management, production and process controls, and training, execution quality system and regulatory gap assessments to identify changes needed to meet FDA regulations at several global device manufacturers to meet FDA regulations vendor management and operations assessments of device manufacturers.

His expertise also include-

  • Remediation to FDA 483s,Warning Letters, and recalls;
  • Remediation to CAPAs, complaints, and NCRs;
  • SOP and training development;
  • Advice on risk mitigation and MDR assessment and analysis;
  • Consultation on unique device identification, cybersecurity and the medical device tax;
  • Global Regulatory Strategy Experience including at Big 4 Consulting Firm.


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