Ukrainian Scientific Institute of Certification
about us

The Ukrainian Scientific Institute of Certification was founded in 2010. The Institute specialized in examination of registration documents on medicinal products and medical devices, including the assessment of the conformity of technical files with the requirements of the European legislation.

The accumulated experience, qualification and knowledge of our employees and an effective management system (MS) in place make us competent and ready to address the issues relating to conformity assessment, including the certification of products and quality management systems. In addition, our employees are well-versed in the Ukrainian and international legislation regulating medical devices, including regulations in the original language.

In 2015, when the technical regulations on medical devices became mandatory, the Institute management, having taken into account the qualification and knowledge of its employees, decided to extend its scope of activities and to obtain from the Ministry of Economic Development and Trade of Ukraine appointment to carry out the assessment of devices conformity with the requirements of the Ukrainian legislation.

In September 2015, Uni-CERT was accredited by the National Accreditation Agency of Ukraine in accordance with ISO/IEC 17021:2011 (certificate of accreditation No. 8O103 of 2 September 2015 and the scope of accreditation) to certify the quality management systems for conformity with:

  • DSTU ISO 9001:2009 Quality management systems – Requirements;
  • ISO 9001:2008 Quality management systems – Requirements;
  • DSTU EN ISO 13485:2015 Medical devices – Quality management systems – Requirements for regulatory purposes;
  • DSTU ISO 13485:2005 Medical devices – Quality management systems – Requirements for regulatory purposes;
  • ISO 13485:2003/Cor1:2009 Medical devices – Quality management systems – Requirements for regulatory purposes;
  • EN ISO 13485:2012 Medical devices – Quality management systems – Requirements for regulatory purposes.

 

and in accordance with ISO/IEC 17065:2012 (certificate of accreditation No. 1O302 of 4 September 2015 and the scope of accreditation) to certify products, specifically:

  • medical devices;
  • active implantable medical devices;
  • in vitro diagnostic medical devices.

 

In December 2015, Uni-CERT was designated as a notified body (Order No. 1764 of the Ministry of Economic Development and Trade of 24 December 2015; identification number: UA.TR.116) to carry out the assessment of conformity with the requirements of the following technical regulations:

  • Technical regulation on medical devices, as approved by Resolution No. 753 of the Cabinet of Ministers of Ukraine of 2 October 2013;
  • Technical regulation on in vitro diagnostic medical devices, as approved by Resolution No. 754 of the Cabinet of Ministers of Ukraine of 2 October 2013.

 

In September 2016, during the planned supervision of the accredited conformity assessment bodies carried out by the National Accreditation Agency of Ukraine, UNI-CERT LLC confirmed its competence in the declared scope ISO/IEC 17021-1:2015 (accreditation certificate as of December 9, 2016 No. 80103) and expanded the scope of activities for the certification of quality management systems for compliance with:

  • ISO 9001: 2015 Quality management systems – Requirements;
  • ДСТУ ISO 9001:2015 Системи управління. Вимоги (ISO 9001:2015, IDT) (DSTU ISO 9001: 2015 Management Systems – Requirements (ISO 9001:2015, IDT)).

 

During the planned supervision of the accredited conformity assessment bodies in accordance with the requirements of ISO/IEC 17065:2012 (certificate of accreditation No. 10302 dated 09.12.2016), UNI-CERT LLC confirmed its competence in the declared scope, and also expanded the scope of activities for the implementation Certification of products, namely:

  • Individual protection means.

 

In January 2017, UNI-SERT changed its actual location, which the National Agency for Accreditation of Ukraine was informed and the existing accreditation certificates were amended, the accreditation certificate of 14.02.2017 № 80103 and the accreditation certificate of 14.02.2017 № 10302.

In accordance with the accreditation certificate No. 80103 of 14.02.2017 and the scope of accreditation, UNI-CERT LLC is authorized to conduct activity on the certification of quality management systems (QMS) according to the following standards:

  • ISO 9001:2008 Quality management systems – Requirements
  • ДСТУ ISO 9001:2009 Системи управління. Вимоги (ISO 9001:2015, IDT) (DSTU ISO 9001:2009 Quality management systems – Requirements (ISO 9001:2008, IDT))
  • ISO 9001: 2015 Quality management systems – Requirements
  • ДСТУ ISO 9001:2015 Системи управління. Вимоги (ISO 9001:2015, IDT) (DSTU ISO 9001: 2015 Management Systems – Requirements (ISO 9001: 2015, IDT))
  • ISO 13485: 2003/Cor 1:2009 Medical devices – Quality management systems – Requirements for regulatory purposes
  • ДСТУ EN ISO 13485:2015 Медичні вироби. Система управління якістю. Вимоги до регулювання (EN ISO 13485:2012, IDT; ISO 13485:2003, IDT) (DSTU ISO 13485: 2005 Medical products – Quality management systems – Requirements for regulation (ISO 13485: 2003, IDT))
  • EN ISO 13485: 2012 Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485: 2003, IDT)
  • ДСТУ EN ISO 13485:2015 Медичні вироби. Система управління якістю. Вимоги до регулювання (EN ISO 13485:2012, IDT; ISO 13485:2003, IDT) (DSTU EN ISO 13485: 2015) Medical devices – Quality management system – Requirements for regulation (EN ISO 13485: 2012, IDT; ISO 13485: 2003, IDT).

 

In accordance with the accreditation certificate No. 10103 of 14.02.2017 and the scope of accreditation, UNI-CERT LLC carries out activity to assess the conformity of products in the following areas:

  • medical devices;
  • active implantable medical devices;
  • medical devices for in vitro diagnostics;
  • individual protection means.

 

We would be happy to answer your questions, please contact us.

Independence

The notified body is independent and impartial; its decisions are based solely on objective evidence of conformity.

Competence

The personnel involved in the conformity assessment process are equipped with appropriate qualification, expertise and professional experience.

Confidentiality

The notified body observes confidentiality of any proprietary information of the client.

Openness

The notified body provides the interested parties with access to information about its audit process, conformity assessment, its status, and to non-confidential information about the conclusions of specific conformity assessments.

Responsiveness to complaints

The notified body ensures that each and every complaint is handled in accordance with the established procedures, thus protecting its clients and applicants against errors.

Responsibility

The responsibility for conformity with the requirements rests with the client. The notified body has the responsibility to carry out the unbiased assessment of evidence of conformity.

Any assessment is based on sampling within a quality management system and therefore is not a guarantee of 100% conformity with requirements.

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