Your Partner In Audit Services
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
Let Elevation's former FDA Investigator lead your team to a successful regulatory submission.
- Mock Pre-Approval Inspection
- DHF or TMF Audit
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
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.