Medical Devices Conformity Assessment Notified Body - UniCERT

[/] Ukrainian Scientific 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 23 experts, including 8 full-time auditors and 6 freelance auditors; Our experience is more than 300 audits in 29 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 02/04/2018 On March 29 VII Ukrainian Forum of Market Operators of Medical Devices was held On March 29 VII Ukrainian Forum of Market Operators of Medical Devices, organized by Association of Market Operators of Medical Devices, ‘Morion’ and ... To read 25/03/2018 IX INTERNATIONAL MEDICAL FORUM, April 25 – 27, 2018 IX INTERNATIONAL MEDICAL FORUM “Medicine Innovations – the Nation’s Health” – large-scale complex innovation-oriented event of the health care indus... To read 16/03/2018 VII Ukrainian Forum of Market Operators of Medical Device, March 29, 2018 Dear colleagues! March 29, 2018 will be held VII Ukrainian forum of market operators of medical devices, which Anna Telpiakova, Quality Assurance ... To read 03/03/2018 Introductory workshop for KNUTD students March 2, at the invitation of the Kiev National University of Technology and Design (KNUTD), we held an Introductory workshop for students of the Comp... To read 23/02/2018 A contract on recognition of the results of the assessment of conformity with DEKRA Certification GmbH Dear colleagues! We are pleased to inform you that the European notified body DEKRA Certification GmbH has signed an arrangement for the recognition ... To read 12/02/2018 European Notified Bodies with whom agreements on recognition of conformity assessment results have been signed Due to the increase of the quantity input of requests on the procedure of the recognition of European Notified Bodies conformity assessment results in... 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