IMPROVE MEDICAL UA.TR.120 is a conformity assessment body designated according to the new standards harmonized with the EU

The designated conformity assessment body IMPROVE MEDICAL UA.TR.120 is one of the first conformity assessment bodies in Ukraine designated by the Ministry of Economic Development in accordance with the latest Ukrainian legislation in the field, which met all accreditation requirements and received accreditation in accordance with the requirements of

– ISO / IEC 17021: 2015 Conformity assessment – Requirements for bodies conducting audit and certification of management systems – Accreditation certificate in accordance with the requirements of ISO/IEC 17021:2015;

– ISO / IEC 17065: 2012 “Conformity assessment – requirements for bodies that certify products, processes and services” – Accreditation certificate in accordance with the requirements of ISO/IEC 17065:2012.

On November 11, 2016, IMPROVE MEDICAL was designated by the appropriate orders No.1898,  No.1899No.1900  and decisins No. 1898,  No. 1899No. 1900 of the Ministry of Economic Development of Ukraine to perform functions of the conformity assessment body of the following technical regulations:

– Technical Regulations on Medical Devices [1];

– Technical Regulations on Active Implantable Medical Devices [2];

– Technical Regulations on In Vitro Diagnostic Medical Devices [3].

IMPROVE MEDICAL has its own modern laboratory of technical tests, which is a mandatory and key requirement of the Law of Ukraine “On Technical Regulations and Conformity Assessment”, harmonized with EU standards, increased requirements for the system of technical regulation of product turnover in the Ukrainian market.

IMPROVE MEDICAL successfully carries out the procedure for change (transfer) of the medical devices conformity assessment body.

IMPROVE MEDICAL UA.TR.120  systematically expands the boundaries in cooperation with the international conformity assessment bodies. There are 15 already concluded agreements on recognition of the medical devices conformity assessment results in the portfolio of IMPROVE MEDICAL.

IMPROVE MEDICAL is a guarantee of a competent audit of the Quality Management System and procedures for assessing conformity with the Technical Regulations.

The experts of IMPROVE MEDICAL will provide conformity assessment and auditing services and advise you with reference to the international best practices minimizing risks and costs for business entities.

Contact person: Galina Goy, auditor at IMPROVE MEDICAL, +38 044 355-50-30, office@improvemed.com.ua

[1] approved by Resolution of the Cabinet of Ministers of Ukraine of 02.10.2013, No. 753;

[2] approved by Resolution of the Cabinet of Ministers of Ukraine of 02.10.2013, No. 755;

[3] approved by Resolution of the Cabinet of Ministers of Ukraine of 02.10.2013, No. 754.