MEDICAL DEVICE REGULATION

EU 2017/745 - Advisory & Support: All you need to know about the new Regulation, transition, changes, challanges, solutions,... 

In 2021, TUKO d.o.o. is proudly celebrating 10 years of successful operation! 

RISK ASSESSMENT

Risk assessment of your medical devices; Trainings and consultancy services in the field of risk assessment.

QUALITY MANAGEMENT SYSTEM

Establishment and maintenance of ISO 9001 and ISO 13485 management systems - customized advisory, trainings,... 

Medical software

CE marking of medical software; Advisory, support and wide knowledge and trainings in the field of medical software.