Audit Performance and Gap Analysis
- Do you need an independent specialist to perform an internal or external audit?
- Are you wondering about your level of compliance and in need of a review?
- Do you need a professional second opinion to prepare for an external audit?
We plan and perform internal and external audits according to all relevant regulatory requirements within the medical device industry.
Gap analysis –aneffective tool for verification of possible compliance misalignment. We have good experience in comparing documents with ISO standards or other authority requirements.
Do you needa second opinion before anauthority inspection or do you need to knowexactlywhere you need to improve? We have a solidexperience in performing audits within different areas e.g. QMS.
An audit performed from our office,based on your documentation. An effective way to get a very detailed evaluation of procedures and technical documentation.
If you need to know the exact gap between your currentdocumentation and a new regulation or standard, we are experts in the legislations and key standards within the medical area.