(044) 285-83-83

(044) 490-27-34

info@umcs.org.ua

Authorities

Conformity assessment of Medical devices

2005 SE “UMSCC” has been accredited as conformity assessment body by National Accreditation Agency of Ukraine in compliance with the requirements of  ISO/IEC 17065:2012; according to the Orders by the Ministry of Economic Development and Trade of Ukraine since 29.08.2014 No.  1044 and since 21.07.2015 No.  846, accredited an authorized body for conformity assessment of medical devices to:
– Technical regulations for medical devices;
– Technical regulations for active implantable medical devices;
– Technical regulations for IVD medical devices.

 

Quality management systems certification

SE “UMSCC” has been accredited a Quality management system certification agency by National Accreditation Agency of Ukraine in compliance with the requirements of ДСТУ EN ISO / IEC 17021-1: 2015 (ISO / IEC 17021-1: 2015) in regard to:
- ДСТУ ISO 13485:2005 «Вироби медичні. Системи управління якістю. Вимоги щодо регулювання (ISO 13485:2003, IDT); ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes; ДСТУ EN ISO 13485:2015 «Медичні вироби. Системи управління якістю. Вимоги щодо регулювання (EN ISO 13485:2012, IDT; ISO 13485:2003, IDT); EN ISO 13485:2012 Medical devices - Quality management systems - Requirements for regulatory purposes»
- ДСТУ ISO 9001:2009 «Системи управління якістю. Вимоги (ISO 9001:2008, IDT); ISO 9001:2008 Quality mangement systems - Requirements; ДСТУ ISO 9001:2009 «Системи управління якістю. Вимоги (ISO 9001:2015, IDT); ISO 9001:2015 Quality mangement systems - Requirements;»

 

Testing

Testing laboratory of SE “UMCC” is accredited by National Accreditation Agency of Ukraine in compliance with the requirements of DSTU ISO/IEC 17025:2006 (ISO/IEC 17025:2006) in regard to: test of medical electrical and portable equipment upon indications:
– identification and marking;
– consumed power;
– voltage, current or power limitation;
– working parts available;
– weight of portable devices.

 

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