1. We can assist you with conformity assessments for your products, ensuring they meet the required quality standards. Our team provides various conformity assessment procedures and supports your project from beginning to end, including obtaining a certificate of conformity.
2. We can help you develop the necessary documents for the Ukrainian market, and translate them. Our experts conduct a diagnostic audit to determine your manufacturer’s capabilities to pass a Quality Management System (QMS) audit, both in Ukraine and abroad.
3. We ensure coordination of the audit plan and prepare the manufacturer for the audit. We also assist in eliminating non-compliances identified by the conformity assessment body, accelerating the conformity assessment process.
4. Our experts provide clear and professional communication in Ukrainian, Russian, and English, making the entire process of conformity assessment and quality systems easy to understand. If necessary, we can also become your authorized representative and support the process of changes after receiving the certificate.
IF YOU HAVE ANY QUESTIONS, THE COMPANY’S EXPERTS WILL PROVIDE FREE CONSULTATIONS
Conformity assessment is the process of checking whether a product meets the requirements of the technical regulations. Once a product passes conformity assessment, a certificate is issued to confirm it meets all necessary requirements.
For high-risk medical devices and other medical devices, certification is carried out through audits of the manufacturer’s quality management system (QMS). This is the most common way to verify the conformity of medical devices.
The QMS audit consists of two stages. In the first stage, the technical documentation for the product is checked. In the second stage, the manufacturer’s QMS is checked. During the QMS audit, all areas specified in the certificate and on the labeling of products intended for sale in Ukraine are checked.
The certificate of conformity is valid for 5 years and covers many different groups of medical devices, allowing manufacturers to market a variety of products in accordance with the necessary requirements.
– Medical devices of high-risk classes (Ia, Ib, IIa, IIb, III)
– In vitro diagnostic products from lists “A” and “B”
– Active medical devices implanted in accordance with the relevant technical regulations
Non-resident manufacturers who want to sell their medical products on the Ukrainian market must undergo a conformity assessment procedure to ensure their products meet the Technical Regulations.
In addition, the manufacturer must undergo annual surveillance of certified products to ensure that the products continue to meet the established requirements.
