CONFORMITY ASSESSMENT OF MEDICAL DEVICES IN UKRAINE

+380(44)355-50-30
GREETINGS FROM THE HEAD

WELCOME to the official website of the socially responsible body for conformity assessment IMPROVE MEDICAL UA.TR.120, which is accredited by the National Accreditation Agency of Ukraine and appointed by the Ministry of Economy of Ukraine to carry out work to assess the conformity of products within the requirements of technical regulations of the medical devices marketed in Ukraine.

IMPROVE MEDICAL fully supports the European path of Ukraine’s development and welcomes the steps that our country is taking in this direction.

IMPROVE MEDICAL guarantees the performance of work at the level of European standards and principles: openly, impartially and in strict accordance with the letter of the law.

BENEFITS
OF COOPERATION
WITH IMPROVE MEDICAL
  • Save your time and money by using our wide network with certification and conformity assessment bodies abroad
  • Get your products on the market faster by taking advantage of our ability to dispatch your products effortlessly by taking using our service to quickly conduct the necessary trials or service testing.
  • Increase the value of your products with the Improve Medical mark, a reliable brand in the field of conformity assessment of medical devices with technical regulations and certification of quality systems.
  • Stay updated on all the official industry innovations with our well-established system for informing customers about new regulatory requirements.
HOW WE WORK?

The IMPROVE MEDICAL team adheres to the following fundamental principles in its work:

  • RESPONSIBILITY We are meticulous about our work and are ready to vouch for the result.
  • COMPETENCE High qualification and experience of employees guarantee the reliability of proven results of our work.
  • PARTNERSHIP Our employees are ready to answer all your questions regarding both conformity assessment procedures and quality system certification.
  • GREETINGS FROM THE HEAD
  • BENEFITS
    OF COOPERATION
    WITH IMPROVE MEDICAL
  • HOW WE WORK?
Our services

iso 9001:2018 quality management

ISO 9001 QUALITY CERTIFICATION

IIMPROVE MEDICAL has all the necessary powers to carry out the certification procedure in accordance with DSTU EN ISO 9001:2018 Quality Management Systems. Requirements (EN ISO 9001:2015, IDT; ISO 9001:2015, IDT); DSTU EN ISO 9001:2015 Quality management systems. Requirements (ISO 9001:2015, IDT); ISO 9001:2015 Quality management systems – Requirements) for enterprises operating in such sectors of the economy as:

– healthcare;

– education, etc.

iso 13485:2018 quality management

ISO 13485 QUALITY CERTIFICATION

IMPROVE MEDICAL is an accredited body for the certification of production in accordance with the standards of DSTU EN ISO 13485:2018 Medical devices. Quality Management System. Regulatory requirements (EN ISO 13485:2016, IDT; ISO 13485:2016, IDT); ISO 13485:2016 (Medical devices – Management systems) in the following technical areas:

– active and inactive medical devices;

– implantable medical devices;

– medical devices for laboratory diagnostics in vitro;

– sterilization methods for medical devices;

– products in which special substances/technologies are used.

iso 9001:2018 quality management

ASSESSMENT OF COMPLIANCE WITH TECHNICAL REGULATIONS ON THE MARKET OF MEDICAL DEVICES

IMPROVE MEDICAL is an accredited and conformity designated assessment body for medical devices under the following Technical Regulations:

– Technical regulations for medical devices, approved by the Resolution of the Cabinet of Ministers of Ukraine No. 753 dated 02.10.2012;

– Technical regulation of medical devices for in vitro diagnostics, approved by the Resolution of the Cabinet of Ministers of Ukraine No. 754 dated 02.10.2012;

– The technical regulation on active implantable medical devices was approved by the Resolution of the Cabinet of Ministers of Ukraine No. 755 dated 02.10.2012.

Seminar

IMPROVE MEDICAL specialists will explain the nuances of the current legislation and the practical aspects of their application.

As part of the policy pursued by IMPROVE MEDICAL of the greatest assistance to business entities, the Information Services Centre has been established in the company. By contacting our Centre, manufacturers and suppliers of medical devices are guaranteed to receive comprehensive advice on the following issues:

01.

– The main aspects of the implementation and application of the Technical Regulations for specific medical products. Features and choice of procedure for assessing compliance with TR. Product labelling requirements.

03.

— Regarding the application of the norms of the current Ukrainian legislation on the circulation of medical devices.

02.

– Features of development, implementation and certification procedures according to ISO 9001:2018/DSTU ISO 9001:2018 and ISO 13485/DSTU ISO 13485 for medical devices in Ukraine.

Використання ISO9001, ISO13485 дозволить

ПОЛІПШИТИ КЕРОВАНІСТЬ ПІДПРИЄМСТВОМ

Система менеджменту якості дозволяє організувати ефективну схему комунікації між усіма підрозділами компанії і, як наслідок, підвищити ефективність управлінських рішень

ПОЛІПШИТИ якість виробленої продукції

Система менеджменту якості дозволяє організувати ефективну схему контролю якості продукції, що випускається і, як наслідок, забезпечити стабільність якісних показників на всіх етапах виробництва

ПОЛІПШИТИ ОБСЛУГОВУВАННЯ КЛІЄНТІВ

Cистема менеджменту якості дозволяє організувати ефективну схему "зворотного зв'язку" з кінцевим споживачем продукції і, як наслідок, підвищити рівень довіри клієнтів до вашої марки медвиробів

OUR ACCREDITATION AND SCOPE

ARE YOU READY?!

INCREASE PROFITABILITY

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INCREASE SALES

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INCREASE PROFIT

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LEARN THE COST OF WORK

for certification and assessment of compliance with the Technical Regulations on the market of medical devices

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CLIENTS OF OUR COMPANY
CONTACTS

IMPROVE MEDICAL LCC

st. Rizhskaya, 8a, office 110,

Kyiv. Ukraine, 04112

E-mail: info@improvemed.com.ua

Skype: improvemedua@gmail.com

+38044 355 50 30

+38073 355 50 30

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