FAQs
Do you conduct audits globally?
Yes, we have a worldwide team of lead auditors and can serve clients in any region.
1
How long does a typical audit take?
2
The duration depends on the audit scope, company size, and complexity of products, but we always define the audit duration during the initial consultation.
What documents will the auditor need to see?
3
Auditors commonly request quality manuals, procedures, work instructions, training records, device history records, complaint files, previous audit reports and evidence of regulatory compliance. For supplier audits the auditor will also request the supplier quality agreement.
What are common findings during medical device audits?
4
Frequent findings include, incomplete documentation, insufficient training records, gaps in supplier qualifications, and non-conformities in complaint handling or corrective actions.
Are your audits confidential?
Strict confidentiality is maintained throughout our engagement.
5
Will you provide mentoring?
Our 80:20 audit approach ensures that 20% of the engagement is dedicated to mentoring, helping your team understand requirements and adopt best practices.
6
Request an Audit
Click the button to contact our medical device audit specialists to discuss your compliance and audit requirements.