ISO 13485:2016 audit in Astrum LT

Over the past year and several months, the management and all departments of Astrum LT have been diligently working on the development and implementation of a robust Quality Management System (QMS). This initiative was undertaken with full commitment to ensure compliance with the ISO 13485 standard, enabling us to design, develop, and manufacture laser devices, electro-optical, and electronic components in accordance with the highest international quality and safety requirements.

During the week of March 24th 2025, Astrum LT welcomed auditors from our ISO certification partner, DQS Holding GmbH, for a comprehensive three-day audit. This intensive yet highly productive evaluation provided us with the opportunity to demonstrate that all our processes comply with the stringent requirements of ISO 13485:2016.

Today, we are proud to announce that Astrum LT has successfully passed the audit and is now in the process of being awarded the ISO 13485:2016 certification (DIN EN ISO 13485:2021 / EN ISO 13485:2016 / A11:2021), marking a significant milestone in our commitment to quality, safety, and excellence in the industry.