KAIROS – Transition from DIN EN ISO 13485:2012 to 2016 Successful
Tested and approved! In February the second supervisory audit by the “Berlin Cert certification agency for health care products” took place in our headquarters in Bochum as well as in our branch office in Berlin. This was then followed by a changeover to DIN EN ISO 13485:2016.
The quality management team was able to successfully guide KAIROS GmbH through the audit. All business areas were audited and were more than satisfactory with a clear and successful QMS. Once again, the certificate was issued for the scope of development, installation, service and distribution of software for merging clinical and research data.
Dr. Miriam Böckmann and PD Dr. Christian Stephan, Quality Management Representative and Managing Partner of KAIROS GmbH.