Certification to EN ISO 13485

Another important milestone for AACMI: the certification according to DIN EN ISO 13485 has been successfully achieved.

Congratulations to the entire AACMI team and to everyone involved who contributed to this important success.

A certification in the medical device industry is far more than a formal achievement. It reflects established processes, traceable documentation, robust validations, and a quality management system that must work not only on paper, but also in daily operations.

The project was carried out in close collaboration between AACMI and DMG MORI. I am grateful that, in my role as technical lead on behalf of DMG MORI, I was able to contribute to this project and support the technical and process-related implementation.

I would especially like to acknowledge the commitment and openness of the team on site. Results like this are only possible when expertise, discipline, collaboration, and the willingness for continuous improvement come together.

For AACMI, this certification represents an important step toward sustainable, quality-assured, and regulatory-compliant manufacturing in the field of medical devices.

With the successful certification, an important milestone has been reached — and at the same time, the next phase begins: the continued development and stabilization of the established processes.

Congratulations to everyone involved on this shared success.