ISO 13485

Quality Management

YOUR QUALITY MANAGEMENT SYSTEM

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EVERYTHING FOR YOUR QM SySTEM

Do you need help in creating or improving your QM system? Or do you need an external expert to put your QM system to the test in the form of a review or internal audit? In any case, we are happy to support you on the way to your audit-ready QM system.

CREATION

We create the QMS for you. Whether individual documents or the entire QMS: our experts work quickly, reliably and ensure the highest quality. Audit-ready documents are created in close consultation with you.

REVIEW

We will do a thorough ISO 13485 compliance check of single documents or your complete quality management system. With our guidance, you will have your documents audit-ready in no time.

INTERNAL AUDIT

We conduct internal audits on-premise or remotely. We plan and conduct the mandatory internal audit for you. All non-conformities will be discussed with you and recorded according to ISO 13485.