Medical Devices Conformity Assessment Body

Identification code UA.TR.116

The Ukrainian Scientific Institute of Certification is a Ukrainian national notified body with accreditation according to ISO/IEC 17021, 17025 and 17065 for conformity assessment of medical devices, medical devices for in-vitro diagnostics and active implantable medical devices.

Our independent and impartial team of experienced auditors and experts has excellent knowledge of English and refer to EU Directives and Guidelines in assessment practice. We understand demands of our Customers and establish the business in modern and transparent way.

Our services:

• National conformity assessment of medical devices (according to Technical Regulations on Medical Devices approved by Resolution of the Cabinet of Ministers of Ukraine No. 753 dated October 2, 2013);
• National conformity assessment of medical devices for in-vitro diagnostics (according to Technical Regulations on Medical Devices for In Vitro Diagnostics approved by Resolution of the Cabinet of Ministers of Ukraine No. 754 dated October 2, 2013);
• Assessment of the technical documentation (Technical file) for national requirements to “self-declaration” procedure;
• Information services regarding medical device classification, review of labeling and others;
• Education and training.

We are trusted by more than 300 international medical device manufacturers since:

• Our team consists of 23 experts, including 8 full-time auditors and 6 freelance auditors;
• Our experience is more than 350 audits in 32 countries;
• We perform assessment of documents and audits in Ukrainian, Russian, English and German languages;
• Our experts report at the industry-specific events and write articles for leading industry information resources;
• Our notified body is a member of the Association of Market Operators of Medical Devices;
• Our notified body is a member of European Business Association (EBA);
• Our notified body is a member of the American Chamber of Commerce (АСС) in Ukraine;
• We have entered into Agreements on recognition of conformity assessment results with leading European notified bodies.

More information about us please can be found on the following page