CAB Improve Medical +380(44)355-50-30

  • Director's Greeting

    Welcome to our sight IMPROVE MEDICAL LLC – authority, which has been accredited in Ukraine to assess compliance of products with the Regulations concerning medical products!

    Cоnfirming its European choice, Ukraine harmonizes its legislation and regulations step by step according to the European rules. As it is known since the 1st of July 2015 the Regulations for the medical products in Ukraine are acting and from the 1st of July 2017 Ukraine completely passed to the standard of  confirmation of the quality and safety of the medical products.

    IMPROVE MEDICAL LLC strongly maintains the European way of development in Ukraine and welcomes the steps to which our country adheres to. From our part we guarantee to work on the level of the European standards and principles: publicly, open-mindedly and in strict adherence to the letter of the Law.

  • Advantages of cooperation with CAB Improve Medical

    Save time and money by using our wide connections with Notified Bodies and Conformity Assessment Bodies.

    Accelerate introduction of your products to the market taking advantage of our ability to promptly conduct the necessary tests or service testing

    Increase value of your products through the mark of Improve Medical – one of the most reliable Ukrainian brands in the field of conformity assessment of medical devices with Technical Regulations and certification of quality systems in the field

    Be aware of all official industry innovations through our tried and tested system of informing the clients about the new regulatory requirements.

  • How we work?

    Personnel of the IMPROVE MEDICAL LLC sticks to its work by the following basic principles:

    Responsibility. We are scrupulous about our work and guarantee proper results.

    Competence.  High qualification and experience of the personnel guarantees the reliability of the results of our work.

    Partnership. Our employees shall answer your questions readily, pertaining both to conformity assessment procedure, and the certification of QMS.

CONTACT US

Specialists of the IMPROVE MEDICAL shall explain peculiarities of the acting legislation and the practicalities of the use of them.

The policy of  IMPROVE MEDICAL consists of the creation of the most favourable conditions for the business entities, founded by the Information Services Center within the company.  Addressing to our Center the manufacturers and suppliers of the medical equipment can always rely on obtaining exhaustive advices on the following questions:

  • Key aspects of the implementation and use of the Regulations for the specific medical devices. Peculiarities and choice of the procedure of the assessment of its compliance with the Regulations. Requirements to the marking of the medical devices.
  • Peculiarities of the development, implementation and procedure of the certification according to ISO 9001:2008/DSTU ISO 9001:2009 and ISO 13485:DSTU ISO 13485 for the medical devices in Ukraine.
  • Explanations concerning use of norms of the acting Ukrainian legislation regarding turnover of the medical devices.

Our Services

Сеrtification of quality ISO 9001

Dialog concept by Artefact_wired

IMPROVE MEDICAL has all necessary powers to conduct the procedure of the certification according to DSTU ISO 9001:2009 and ISO 9001:2008 for enterprises working in the following economic sectors:

  • pharmaceutics;
  • protection of health;
  • education etc.

Сеrtification of quality ISO 13485

Dialog concept by Artefact_wired

IMPROVE MEDICAL is the accredited authority concerning Certification of the products according to the standards DSTU ISO 13485:2015 and EN ISO 13485:2012 in the following technical sectors:

  • Active and non-active medical devices;
  • Implantable medical devices;
  • Medical products for the laboratory diagnostics in vitro;
  • Sterilization methods for medical devices;
  • Products, in which special substances/technology are used.

Conformity assessment body

Dialog concept by Artefact_wired

The IMPROVE MEDICAL LLC is an accredited authority concerning the assessment of the compliance of the medical products with the following Regulations:
— № 753 «Medical products»;
— № 754 «Medical products for the diagnostics in vitro»;
— № 755 «Аctive medical products for the implantation».

Our team

Svetlana Zgonnyk
Head of Conformity Assessment Department
Tetiana Pazerska
Managing director
Maria Slabinska
Laboratory chief
Valentin Dembitsky
Test Lab Engineer

Application for CERTIFICATION

All you will need to do is fill in some simple fields, and we’ll get in touch with you soon.

News

January 17, 2018 in News

(Русский) Improve Medical заключает соглашения с крупнейшими Нотифицированными Органами Европы о признании результатов оценки соответствия медизделий

Read Story
December 8, 2017 in Training announcement

(Русский) Обучающий онлайн-курс «Подготовка кандидата в аудиторы и внутреннего аудитора по сертификации систем управления качеством в соответствии с требованиями ISO 13485:2016»

Read Story
September 26, 2017 in Expert Interviews

(Русский) БЕЗОПАСНОСТЬ МЕДИЦИНСКИХ ПРИБОРОВ. СИСТЕМА ПОСТ-МАРКЕТИНГОВОГО НАДЗОРА У ПРОИЗВОДИТЕЛЯ И ЕГО УПОЛНОМОЧЕННОГО ПРЕДСТАВИТЕЛЯ. ЕВРОПЕЙСКИЙ ПОДХОД.

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September 22, 2017 in News

(Русский) IMPROVE MEDICAL совместно с AMOND и «МОРИОН» проводит уникальный семинар о постмаркетинговом надзоре на рынке медизделий

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September 17, 2017 in Expert Interviews

Improve Medical: We take into account that some technical documents of the manufacturer of medical products is confidential.

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September 5, 2017 in News

(Русский) IMPROVE MEDICAL представит новейшую информацию о легализации медизделий на октябрьской глобальной выставке в Киеве

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September 4, 2017 in Vlog

(Русский) IMPROVE MEDICAL 31 августа провел бесплатный обучающий вебинар о легализации медизделий в Украине (ВИДЕО)

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August 23, 2017 in News

Improve Medical: Seal of conformity agencies on declaration of conformity of medical products is not required

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August 23, 2017 in News

(Русский) IMPROVE MEDICAL 31 августа обучит эффективным способам легализации медизделий в Украине

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