We provide audit expertise that can more effectively drive change and improvements. Your internal audit will be conducted by certified lead auditors with extensive audit experience and people skills.
We will conduct the internal audit for you according to your own schedule and procedures.
At your request, we can also target areas or divisions where we dig deeper to uncover the nonconformities behind the challenges you may encounter.
We will prepare plan, audit checklists, corrective actions and audit reports in compliance with ISO 9001, ISO 13485, CE marking, CMDCAS and FDA internal audit requirements and ISO 19011.
We will also follow up to close corrective actions and verify activity.
Supplier Audit
If you are producing on behalf of your own brand in a third party company and you want to make sure that your supplier provides this service to you in accordance with the current and valid Medical Device Regulations and other relevant standards, we can audit your critical supplier on your behalf.
