Development of technical and operational documentation for the purposes of registration of medical products

Development of technical and operational documentation for medical products is a fundamental step in ensuring their safety and efficiency. High-quality technical and operational documentation that meets the requirements of regulatory documents represents the essential source of information about a medical product and is of key importance for authorized bodies when making a decision on state registration

Errors committed in the process of developing technical and operational documentation submitted to the registration authority may result in the refusal of registration of a medical product and, consequently, in huge monetary and time costs for the manufacturer.

To avoid these potential problems, it is important to work with professionals who have a thorough understanding of regulatory requirements and industry practices. Our company Electrontest LLP assists in the development and revision of technical and operational documentation for medical products, offering full customer support throughout the entire process

Our team has decades of experience in developing and revising technical and operational documentation for a wide range of medical products, including diagnostic equipment, surgical instruments and implantable devices. We work closely with our clients to understand their exact needs and offer customized solutions to meet them. Our task involves developing or adjusting the highest possible quality document in accordance with the requirements of the National Regulatory Authorities of the EAEU member states and EEC decisions, meeting all current regulatory requirements

Electrontest LLP in its work relies on many years of experience of its employees in the registration of medical devices in the Republic of Kazakhstan and the Russian Federation. We provide a comprehensive approach to the registration process. If necessary, we, together with the testing centers of the Electrontest group of companies, provide the full range of tests of medical devices necessary for their registration: technical, toxicological, clinical and clinical-laboratory tests of In Vitro products.

Our services

· Development/refinement/adjustment of technical documentation for the purposes of state registration of a medical product (extract from the technical file, technical specifications);
· Development/refinement/adjustment of operational documentation for the purposes of state registration of a medical product (operating manual, instructions for use);
· Development/refinement/adjustment of the risk management file for a medical product (analysis of risk assessment of the use of a medical product at each stage of its life cycle);
· Development/refinement/adjustment of reports required for medical product registration purposes;
· Development of informational, explanatory letters required for the purposes of medical product registration;

• Refinement/adjustment of documentation in case of refusal in registration of a medical product received during self-registration or by third-party companies.

Astana, st. Anet baba, 9/3

+7 (776) 326 2500
+7 (702) 999 1964
+7 (701) 419 2225

Our work is based on a deep knowledge of regulatory documents, an understanding of the physics of processes in medical devices, the high qualification of our experts and, most importantly, on our own test base.

Company group

Our services

Contacts

_{For request:}
electrontest.kz@gmail.com