Internal audits and audits of sub-contractors manufacturing medical devices

We can perform your internal quality management system audits and prepare your technical dossiers according to the chosen standard (EN ISO 13485:2016, 21 CFR Part 820, MDSAP, Canada Requirements, DM/DMDIV Directives or Regulations).

In the frame of the monitoring and evaluation of your medical devices’ suppliers and manufacturers, we can also offer to act as a third parties for the audit of your sub-contractors.

See also our training in audit practices


ImpartialitY AND professionnalism

The outsourced internal audit allows you to take a different look at the state of your quality management system and opens new opportunities for improvement. It is also an effective way to highlight any non-compliances that may not have been detected during previous routine audits.

In addition to the internal audit service, we can support you in the compliance of your quality management system with an educational, pragmatic and considerate approach designed to improve your performance and your effectiveness.

ObjectiVe OF audits

Verify the compliance of your quality management system with regulatory requirements
Decide on the system’s ability to achieve your objectives.
Allow you to identify improvement actions
Prepare you for certification audits