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 News Conformity assessment QMS certification Registry certificates TESTING LABORATORY Policies and procedures Contact information 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 ; 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 14/06/2017 Business Forum of the Improving Healthcare in the Service of People Project On 9 June, a business forum on medical devices was held as part of the Improving Healthcare in the Service of People Project. The event was organized ... To read 09/06/2017 Labelling of medical devices and instructions for use, and manufacturers’ names and locations in the Ukrainian language Dear colleagues! On July 1, 2015, the Technical Regulations on Medical Devices (Resolution of the CMU No. 753 dated October 2, 2013), the Techn... To read 25/05/2017 Routine work on the server! Dear colleagues! Scheduled maintenance work is on the server. Breaks can be observed in the work of the site and e-mail. We apo... To read 23/05/2017 A contract on recognition of the results of the assessment of conformity with ITALCERT S.r.l. Dear colleagues, We are pleased to inform you that the European notified body ITALCERT S.r.l. has signed an arrangement for the recognition of conf... To read 28/04/2017 Summary of the workshop “REQUIREMENTS OF ISO 13485 | INTERNAL AUDITS | RISK ANALYSIS” On 20 April 2017, the workshop titled "REQUIREMENTS OF ISO 13485 | INTERNAL AUDITS | RISK ANALYSIS" took place. In 4 hours of this club-format event, ... To read 18/04/2017 REQUIREMENTS OF ISO 13485 | INTERNAL AUDITS | RISK ANALYSIS, 20 April 10:00–14.00 On 1 July 2015, conformity with the Technical regulations on medical devices became mandatory in Ukraine, and on 1 July 2017 ends the transition perio... To read 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