Auditing services

Auditing services for medical devices industry

We develop effective yearly audit plans that turn auditing into an effective tool, not just a mandatory requirement.

Internal audits

Internal audits are part of the continuous improvement of the QMS and are mandatory. They identify gaps and the effectiveness of your quality management system. Internal audits give you confidence that regulatory requirements are accurately implemented in your processes.

We view internal audits as ways to improve rather than solely for compliancy to get the most of out of your QMS.

• full ISO 13485 QMS audit
• partial ISO 13485 audit, such as only management responsibility
• full or partial ISO 9001 audit
• full or partial ISO 13485+9001 audit
• full or partial ISO 13485 audit + MDR/IVDR 
• full or partial ISO 13485 audit with emphasis on applicable standards such as IEC 62304 or IEC 62366.