RAA – specialized consulting agency for conformity assessment, registration and certification of medical devices with more than 10 years of experience in the regulation of medical products on the Ukrainian market. Our goal is to obtain for you all the necessary certificates, licenses, permits for the free sale of products on the Ukrainian market in accordance with existing regulatory requirements. We have certified dozens of medical devices of various risk classes, technical complexity and various fields of application. We are the company that provides results, along with an individual approach to each client and affordable prices for our services.
OUR MAIN ACTIVITIES:
With the entry into force of the Technical Regulations of Ukraine on medical devices and the appearance in the legislation of such a definition as an Authorized Representative, we offer our agency as an independent professional representative.
MEDICAL DEVICE REGISTRATION
From the beginning to the end: selection of a conformity assessment procedure, preparation of the technical documentation, constant contact with conformity assessment bodies, experts, laboratories to guarantee the timing of registration of medical devices.
Preparation of the technical documentation, the creation of particular modules, writing instructions, development of labeling. Analysis of the manufacturer’s existing documentation, determination of standards and necessary tests for a specific type of product.
Market analysis, risk assessment, product classification and obtaining permits. We guarantee and are constantly working to ensure that you comply with all national standards, mitigating risks and ensuring the safety of your business.
Support or organization of the delivery and customs clearance of samples, marketing materials, finished medical products for clinical trials, testing for the conformity assessment of the lot.