Your Partner In Audit Services


Internal Audits

We act as your internal or external auditor for...
-Routine Internal QMS Compliance Audit
-3rd Party Objective QMS Compliance Audit

  • ISO 13485
  • ISO 9001
  • 21 CFR 820
  • IEC 62304
  • GCP

Submission Audits

Let Elevation's former FDA Investigator lead your team to a successful regulatory submission.

  • Mock Pre-Approval Inspection
  • DHF or TMF Audit

Partner Audits

Elevation performs due diligence audits for PHARMA clients to assess a CDx partner's

  • QMS Compliance
  • Clinical Trial Performance

For our DIAGNOSTIC manufacturing clients, Elevation can perform

  • GMP Audits of Manufacturing Suppliers
  • GCP Audits of Clinical Trial CROs

Auditor Training

Elevation's audit training team can ensure your medical device development team is ready to execute a successful regulatory inspection.

  • Mock FDA Inspection for 21 CFR 820 (GMP)
  • Mock BIMO Inspection

Ready to find out more?

Contact us today with questions or to discuss your project.