Kasve has a vast experience in the CE registration of medical devices, building up ISO 13485 -compliant quality management systems, quality control of medical device software (IEC/EN 62304), risk management of medical devices (ISO 14971) and international business of health technology companies.
We have helped several companies to design and develop their products and quality management systems to meet the requirements of ISO 13485 and to register their product as CE-marked medical devices. We have helped our customers to reach international markets for example in Central Europe and Russia.
