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

April 22, 2018 in News

(Русский) Легалізація медвиробів в Україні: чому постачальникам не треба панікувати з приводу поставок електрообладнання!

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April 12, 2018 in Training announcement

(Русский) Вебинар: «Оценка соответствия медизделий ТР путем признания Сертификата СЕ» – 19 апреля 2018 г.

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April 2, 2018 in News

(Русский) Improve Medical: Как избежать остановки сертификата соответствия при легализации медизделий в Украине

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March 29, 2018 in Expert Interviews

(Русский) Improve Medical: Достоверный расчет цены услуг по оценке соответствия медизделий – залог надежности сертификата соответствия

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March 28, 2018 in News

Improve Medical enters into agreements on recognition of medicinal products conformity assessment results with the largest Notified Bodies in Europe

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March 12, 2018 in News

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

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March 6, 2018 in News

International women’s day wishes greetings

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March 6, 2018 in Training announcement, Expert Interviews, News

IMPROVE MEDICAL provides sponsorship to the VII Ukrainian forum of market operators of medical devices

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February 14, 2018 in News

(Русский) Обучающий онлайн-курс «Подготовка внутренних аудиторов системы управления качеством в соответствии с требованиями ДСТУ ISO 9001:2015»

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