17 Nov MDR certification – ARTIQO prepares for the future
From left to right the ARTIQO quality team: Achim Poos, Lukas Lehmann, Dr. Heidrun Jablonski, Mario Frank
MDR certification – ARTIQO prepares for the future
The changeover from the currently applicable MDD to the new MDR directive is a major challenge for all medical technology companies. ARTIQO has now cleared the first hurdle. Our certification audit according to DIN EN ISO 13485:2021 took place in September. This current version of the standard represents the connection between the contents of EN ISO 13485:2016 and the essential safety and performance requirements of the EU 2017/745 (MDR) regulation on medical devices. In preparation for our certification, we were able with the full commitment of the entire team raise our quality management system to the new legal regulations of Annex 2021 and the requirements of the MDR and thus complete the audit with great success.
Welcome to the team,
Lukas Lehmann
In preparing for certification, we also had the support of our newest team member. Lukas Lehmann has been strengthening our QM department in his position as quality manager since May 2022. As a qualified biologist, Mr. Lehmann was previously employed in hygiene and cleaning research. There he was able to gain experience that enabled him to quickly familiarize himself with our system and QM-relevant issues.
At ARTIQO, Mr. Lehmann is responsible for the maintenance and further development of the quality management system according to DIN EN ISO 13485 and MDR. He is also responsible for monitoring and controlling internal processes and conducting internal audits.
For our customers and partners, Mr. Lehmann also acts as a contact person in the area of complaint management.
We are pleased that Mr. Lehmann has found his way to us and wish him continued success in our team.