KAIROS Obtains System Certification According to DIN EN ISO 13485:2012
Since July 2017 the KAIROS quality management system is certified in accordance with the DIN EN ISO 13485:2012. This certification includes the scopes development, installation, services and sales of software which merges clinical and research data in order to assemble and support an expert system. Besides fulfilling the DIN EN ISO 13485 standards, KAIROS also complies with the European Medical Device Directive 93/42/EEC. Furthermore, KAIROS established a risk management and a risk analysis for medical devices according to DIN EN ISO 14971. Besides, the standards of the DIN EN 62304 (medical software – software-life cycle-processes) are fulfilled as well. 91 quality-based documents – 59 Standard Operation Procedures (SOP), 13 Standard Operation Procedures Software Development (SWD), 4 Work Instructions (WIN) and 15 Policies – are currently used at KAIROS in order to ensure the quality of our entire workflows. CentraXX’ focus is on the scope of the medical purpose and on the patient’s safety, so that the certification of the workflows was not only necessary according to DIN EN ISO 9001 but also in accordance with DIN EN ISO 13485. Thus, the KAIROS GmbH met the essential condition of bringing their expert system CentraXX as a medical device (risk category 1) to the market.
Responsible for the implementation of the quality management system and the further compliance with the embedded processes was and still is the quality management department of the KAIROS GmbH. The certification was done by the “Berlin Cert – Testing and Certification of Medical Appliances GmbH”.
»With the successfully completed certification we now reached an important goal after two and a half years of hard work. The fact that our ›considerable quality management‹ has been certified to us, is, besides the reward, a real additional motivation for the entire KAIROS team.«, Martin Zünkeler, PD Dr. Christian Stephan, managing partners of the KAIROS GmbH.