Vision

With simple processes to safe medical devices.

Mission

We offer you professional support in setting up and developing efficient QM systems.

You can also benefit from our expertise in the approval of medical devices.

Experience

Take advantage of our 20 years of experience in handling quality systems and medical devices of all risk classes.

Philosophy

„Those who know the goal can decide. Whoever decides will find peace. Whoever finds peace is safe. If you are safe, you can think. Those who think can improve.”

Konfuzius

Solutions

We work with you to create lean and individual solutions that meet your needs. You always remain independent.

Conformity

Of course, we always take into account all applicable regulatory requirements.

e.g. ISO 13485,
so far MDD/AIMD/IVDD,
in future MDR/IVDR