Medical Device Compliance Audits and Assessments

Using a risk-based strategy, Regulatory Compliance Associates® (RCA) will help your company by assessing the current state of compliance.  Whether you are trying to assess readiness for an FDA Inspection or would like to understand what gaps exist in your QMS, RCA can assist.

• Mock Inspection (QSIT Audit)
  • FDA Audit Preparation
  • FDA Audit Training
  • FDA Audit Support
• Gap Assessments
  • QMS Gap Assessments
  • CFR Part 11 Gap Assessments
  • Risk Assessments
• Quality Systems
  • FDA 21 CFR part 820 Audit
  • ISO 13485 Audit
  • Development of Inspection Checklists

•  Audits
  • Internal Audits
  • Contract Manufacturer Audits
  • Supplier Audits
• Medical Device Single Audit Program (MDSAP)
  • MDSAP Compliance Audit Readiness