Conformity assessment is a process that proves the fulfilment of regulatory requirements regarding a product, service, process, etc.
IMPROVE MEDICAL LLC (IM LLC) is a designated conformity assessment body (Identification number of the body UA.TR.120) to carry out work on product conformity assessment with the following technical regulations:
- on medical devices, approved by the Resolution of the Cabinet of Ministers of Ukraine dated 02.10.2013, No. 753 (order of the Ministry of Economy and Economic Development of Ukraine dated 12.01.2021 No. 36)
- medical devices for in vitro diagnostics, approved by the Resolution of the Cabinet of Ministers of Ukraine dated 02.10.2013, No. 754 (order of the Ministry of Economy and Economic Development of Ukraine dated 12.01.2021 No. 38);
- for active implantable medical devices, approved by the Resolution of the Cabinet of Ministers of Ukraine dated 02.10.2013, No. 755 (Order of the Ministry of Economy and Economic Development of Ukraine dated 01.13.2021 No. 41).
The cost of conformity assessment work depends on the type of work, the number of documents required for the analysis and the number of production sites or subcontractors. vitro also needs to carry out a design verification procedure).
To start work on IM LLC, you need to submit an application for carrying out conformity assessment work. (Remember that the signature of the medical device manufacturer is required).
You can find the required applications at the following links:
- application for work on conformity assessment of medical devices (filled in bilingually);
- Application for work to verify the design of medical devices according to the requirements of TR 753;
- Application for work on verification of the design of medical devices for in vitro diagnostics in accordance with the requirements of TR 754;
- Application for work to verify the design of active implantable medical devices in accordance with the requirements of TR 755.
Please send the completed forms and the required list of documents tol info@improvemed.com.ua.
Improve Medical LLC (IM LLC) evaluates the conformity of mass-produced products. The procedure involves an audit of the manufacturer and all production sites (where critical manufacturing processes such as design, development, production, and final inspection of medical devices take place). The certificate, which is the result of the conformity assessment, is issued for 5 years. Every year, the manufacturer needs to confirm compliance with the requirements of the Technical Regulations by means of surveillance audits (the CAB is obliged to inspect production sites once a year).
If you have any questions about filling out an application, choosing a conformity assessment procedure or a list of documents, you can contact us by phone +38 044 355 50 30 or by e-mail info@improvemed.com.ua.
Improve Medical experts are always happy to help you find the best solution for you.
Conformity assessment plays a key role in ensuring the quality and safety of products, services, and processes, based on the results of such an assessment can be trusted. Improve Medical LLC (IM LLC) provides its customers with comprehensive conformity assessment services in compliance with relevant standards and regulatory requirements.
In addition, IM LLC provides consulting services for the preparation of documentation, the selection of optimal conformity assessment procedures and the determination of the necessary steps to obtain a certificate of conformity. Our experts provide an individual approach to each client and consider the peculiarities of their products or services.
Cooperating with IM LLC, you can count on the timeliness, responsibility, and professionalism of our employees, who are always ready to help you at all stages of the conformity assessment process. We suggest that you follow the recommendations for completing applications so that cooperation takes place as quickly and efficiently as possible.
For your convenience, IM LLC offers a range of information materials and visual guides to help you understand the conformity assessment process and the requirements of regulatory authorities. We constantly update our knowledge and track changes in legislation to provide you with the most up-to-date and accurate information in accordance with current regulatory requirements. This approach allows us to provide high quality services and timely receipt of a certificate of conformity for our customers.
In addition, IM LLC strives to actively cooperate with customers at all stages of conformity assessment. We provide support during audits, staff training and advice on improving the quality management system. Thanks to this, our customers receive not only a certificate of conformity, but the opportunity to improve their efficiency and competitiveness in the market.
It should also be noted that IM LLC offers services of regular monitoring of production processes, which helps to maintain constant quality control and product compliance with the requirements of technical regulations. Given the high dynamics of the medical device market, this approach is an essential element of successful business.
We hope that our conformity assessment services will help you ensure the safety and quality of your medical devices, services or processes, as well as confirm their compliance with regulatory requirements. Contact us by phone +38 044 355 50 30 or by e-mail info@improvemed.com.ua and our experts will be happy to help you in your business.
1.БЛОК-СХЕМА ПОРЯДОК ОВ (PROCEDURE FOR CONFORMITY ASSESSMENT OF MEDICAL DEVICES IN UKRAINE
2. Порядок надання сертифікації та відмови у видачі сертифіката
3. Порядок підтримування сертифікації та повторної сертифікації
4. Порядок призупинення, поновлення та скасування/анулювання сертифікації
5. Порядок скорочення сфери сертифікації
