OUR QUALITY SYSTEMS
Our Quality Systems; It consists of three main categories as Technical, Scientific and Managerial.
Technical Quality System
Signal Therapy Device
It has passed TS EN 60601-1-2 LVD and EMC Safety tests.
Passed TS EN 60335-1:2012 LVD Low Voltage Directive Tests.
It is CE certified in TS EN 60335-1: 2012 Standard.
Production Quality System
TS EN 13485: 2016 Medical Device Production Quality System
TS EN ISO 9001: 2015 Quality Management System
It is integrated with TS EN ISO 14001: 2015 Environmental Management System.
Quality Tracking System
Dr Biolyse®PET Device is a living device that can report its data to the management cloud by performing its own quality control and calibration. In case of quality problems, the device and/or management cloud provides all safety measures, including device stoppage, and monitors patient welfare in real-time.
Treatment Tracking System
Dr Biolyse®PET devices are managed by the system where the treatment data is transmitted to the relevant parties with transparency by transmitting the location, user, patient and disease on the world in real time to the management cloud.
(Publicly shared data is patient data other than personal data.)
Management Quality System
TS EN ISO 9001: 2015 Management Quality System
TS EN ISO 14001:2015 Environmental Management System
Scientific Studies Quality System
Scientific studies on animals can be carried out within the framework of certain ethical and legal criteria. Our quality system at the level of clinical studies. Clinical studies on humans are carried out within the framework of Good Clinical Practices (GLP) ISO 14155 quality standard.