An internal audit should do more than confirm that procedures exist. Ours are designed to provide clarity, identify the gaps underneath the obvious ones, and make sure you are genuinely prepared for the regulatory and certification requirements ahead of you.
Compliance Management Solutions performs independent internal audits in accordance with ISO 19011.
When an independent audit helps
Typically when you are preparing for ISO 13485 certification, working toward MDR, IVDR or MDSAP compliance, facing a regulatory inspection, or strengthening a quality management system that has not been tested from the outside.
What the audits cover
- MDR, IVDR, MDSAP, ISO 13485 and related regulatory frameworks
- Comprehensive gap assessments with structured, readable reporting
- Clear identification of nonconformities, each supported by a practical recommendation
Why an external auditor
Our auditors bring industry and regulatory experience, an independent and objective view, and audits tailored to your processes and risk profile rather than a generic checklist. The reports are concise and written to support a decision, not to demonstrate effort.
To schedule an internal audit, please contact our regulatory team.