Audits
Preparation for external audits and inspections as well as the implementation of necessary measures after an audit are an integral part of our daily work. With our comprehensive expertise, we support you in optimally setting up your quality management system (QMS) – whether in your own company or with your suppliers.
Internal audits for sustainable quality assurance
An independent internal audit of your QMS provides valuable insights and reveals potential for improvement. Our external perspective helps you critically examine existing processes and identify gaps in the system.
Expertise in leading standards and regulations
Our experience covers a wide range of internationally recognized standards and regulatory requirements:
- ISO 13485
- ISO 9001
- IATF 16949
- ISO 14971
- EU MDR (Medical Device Regulation)
- EU IVDR (In Vitro Diagnostic Medical Devices Regulation)
- MDSAP (Medical Device Single Audit Program)
- FDA 21 CFR Part 820 QSR (Quality System Regulation)
- And other standards and country-specific regulations
Your added value – competent, efficient, practical
With our many years of experience and expertise, we ensure that you not only meet audit requirements, but are also able to optimize your processes in the long term. Benefit from our practical advice and customized solutions that are tailored specifically to your needs.
Would you like to move your company forward?
Let’s take the first steps together!
Do you want to move
your business forward?
Let’s take the first steps together!