Medical Devices Conformity Assessment Notified Body - UniCERT

[/] Ukrainian Research Institute of Certification EN RU UA +38 044 227-41-46 +38 044 338-07-82 Kiev, Kudryavsky descent 7, office 320 About us Conformity assessment QMS certification TESTING LABORATORY Registry certificates News Policies and procedures EDUCATION CAREER CONTACT UniCERT Medical Devices Conformity Assessment Notified 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 20 experts, including 8 full-time auditors and 6 freelance auditors; Our experience is more than 250 audits in 28 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 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 news 03/01/2018 The unified VAT rate is of 7% for all medical devices from January 1, 2018 January 1, 2018, entered into force Law of Ukraine dated 07.12.2017 № 245-VIII "On Amendments to the Tax Code of Ukraine and Certain Legislative Acts ... To read 28/12/2017 About the 2017… 2017 turned out to be very eventful for us and only good impressions from it. We made a qualitative and quantitative leap forward and this is noticeab... To read 26/12/2017 A contract on recognition of the results of the assessment of conformity with LRQA Dear colleagues! We are pleased to inform you that the European notified body Lloyd's Register Quality Assurance (LRQA) has signed an arrangement f... To read 25/12/2017 UNI-CERT is a new member of the American Chamber of Commerce (ACC) in Ukraine We are pleased to announce that UNI-CERT became one of 73 new members of the American Chamber of Commerce (АСС) in Ukraine in 2017. We are confident t... To read 07/12/2017 ISO 13485:2016. Switch to the new version of the standard. On December 4-5, SGS conducted training "ISO13485:2016. Quality management systems for the production of medical devices. Switch to the new version of... To read 23/11/2017 TÜV SÜD expresses its support for the certification of medical devices in Ukraine TÜV SÜD, the European notified body, affirms about its presence in Ukraine, as in a country that has the opportunity to conduct the procedure of recog... To read All news Uni cert Contact us "] 04053, Kiev, Kudryavsky descent 7, office 320 +38 044 227-41-46 +38 044 338-07-82 office@uni-cert.ua 2017 © UniCERT. Все права защищены