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
Background

Our Services

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».

Testing laboratory

Dialog concept by Artefact_wired

Our medical device testing services help you solve non-routine, unusual, and highly complex problems.  Avomeen is FDA, GLP, and cGMP compliant, DEA-Licensed (class I-V), and ISO 17025-Accredited.

Information services

Dialog concept by Artefact_wired

Specialists of the IMPROVE MEDICAL shall explain peculiarities of the acting legislation and the practicalities of the use of them.  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.
–  Explanations concerning use of norms of the acting Ukrainian legislation regarding turnover of the medical devices.

Background

Our team

Tetiana Pazerska
Managing director
Oleh Us
Lead auditor
Tetiana Kolesnik
Project manager
Olena Hoi
Lead Auditor
Svetlana Zgonnyk
Head of Conformity Assessment Department
Maria Slabinska
Laboratory chief
Valentin Dembitsky
Test Lab Engineer

News

IMPROVE MEDICAL UA.TR.120 is a conformity assessment body designated according to the new standards harmonized with the EU
October 12, 2018

The designated conformity assessment body IMPROVE MEDICAL UA.TR.120 is one of the first conformity assessment bodies in Ukraine designated by the... Read More
Post-marketing supervision on the European pattern in Ukraine: how to avoid financial losses by operators of the market of medical devices?
September 12, 2018

On July 1, 2017, the so-called “transition period” for introduction of new rules for legalization of medical devices in Ukraine (note:... Read More
Legalization of medical devices in Ukraine: why suppliers do not have to panic about supply of electrical equipment!
May 20, 2018

Since the end of September 2017, Resolution of the Cabinet of Ministers of Ukraine “On Approval of the Technical Regulations for…

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Improve Medical cooperates with the German DQS in the field of recognition of conformity assessment results. The latter consists of 14 companies
May 15, 2018

The designated Conformity Assessment Body Improve Medical (Ukraine) concluded the agreement on recognition of medical devices conformity assessment results with the…

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Improve Medical cooperates with the German MDC in the field of recognition of conformity assessment results. The latter consists of 13 companies
May 2, 2018

The designated Conformity Assessment Body Improve Medical (Ukraine) concluded the agreement on recognition of medical devices conformity assessment results with…

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Improve Medical cooperates with the German MEDCERT in the field of recognition of conformity assessment results.
April 25, 2018

The designated Conformity Assessment Body Improve Medical (Ukraine) concluded the agreement on recognition of medical devices conformity assessment results with the…

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Improve Medical: How to avoid termination of the certificate of conformity during legalization of medical devices in Ukraine
April 8, 2018

In the previous publication the cost of the conformity assessment procedure of medical devices with the Technical Regulations and the audit... Read More
Improve Medical: Accurate calculation of the price of services for conformity assessment of medical devices is essential for reliability of the certificate of conformity
March 8, 2018

Violation of international standards and legislation of Ukraine during calculation of standard time for the conformity assessment of medical devices with…

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Webinar : “Procedures for conformity assessment with technical regulations on medical products in Ukraine”.
February 18, 2018

Dear colleague, Since July 1 st , 2017 all suppliers of medical devices in Ukraine have been obliged to follow radically new procedures for conformity assessment with technical regulations on medical devices. Have you been already provided…

Read More