Start of the year: Quality measures and successes in medical device manufacturing

Our team is currently placing a strong emphasis on all quality-related aspects and audits, which typically occur in the first quarter of each calendar year.

We successfully completed our internal DIN EN ISO 13485 Audit, with the valuable external assistance of Christian Groß from KKT. This foundational activity has provided us with valuable internal feedback, guiding us on areas for improvement and increased focus.

As part of our annual routine, one of our initial actions is to re-evaluate and recondition our cleanroom facility in accordance with DIN EN ISO 14644. This year, we are pleased to report excellent results across all aspects, including volume exchange and pressure differences. This success ensures our ability to maintain particle-minimal manufacturing conditions for our critical medical devices—ISO class 6 conditions within the room and ISO class 4.7 conditions under the safety benches.

Despite uncertainties, our new projects are progressing with great focus and speed. We are actively preparing for future challenges, demonstrating the resilience and commitment of the Römmler team.