In the modern world medical devices (MD) play a key role in healthcare system. The main quality criteria of MD is safety and guarantee safety - qualified testing.
UkrTEST provides compliance tests of MD in accordance with requirements Ukrainian national standards, European standards (EN) and International standards (IEC/ISO) in the field of medical electrical equipment.
OUR ADVANTAGE
One test, one certificate –
UkrTEST offers a unique opportunity to test medical devices for compliance with safety, electromagnetic compatibility and requirements for radio equipment. After all, this reduces the cost and time to test before gaining access to the market. UkrTEST provides assessment of the risk management process in accordance with the requirements of ISO 14971: 2007; EN ISO 14971: 2012; IEC 60601-1: 2012; IEC 60601-1-2: 2014.
UkrTEST as a member of IEC System of Conformity Assessment Schemes for Electrotechnical Equipment and Components (IECEE) provides testing and certification of MD in international system for mutual acceptance of test reports and certificates IECEE CB Scheme. IECEE CB certificate and test reports are recognized internationally (52 countries) that helps manufacturer to reduce trade barriers caused by different certification criteria in different countries and to get access to new markets faster while reducing overall manufacturing costs.
Pre – compliance test is one of the most reliable ways to control efficient of design solutions. UkrTest provides pre compliance test for basic safety, essential performances and in accordance with all requirements of the standards.
One device, one place of testing –
UkrTEST propose unique opportunity to test Your MD in accordance with Safety, EMC and requirements to the Radio technology in one place that is good way to reduce cost and time for compliance tests before getting access to the market.
Risk management – UkrTEST provides assessment of the risk management process in accordance with requirements ISO 14971:2007; EN ISO 14971:2012; IEC 60601-1:2012; IEC 60601-1-2:2014.
Please refer to our scope for the more details:
