Certification of medical devices
The market of medical devices and medical equipment is one of the most developed branches of the global industry. In addition, because Ukraine chose European course of development, there is an increasing number of technical regulations, which regulate the sector of medical devices among other things. Their primary function is to improve quality of life and increase life expectancy. This market is under constant surveillance of regulating authorities. Our goal is to help our customers to achieve their goals in the best possible way, to provide guidance in a dynamic regulatory policy and an active position concerning the protection of market interests in the public authorities.
We will help in carrying out the appropriate procedure and obtaining the Certificate or Declaration of Conformity for the medical device. We will develop a technical file, prepare an Application and complete the dossier for submission to a specialized examination for samples research, after carrying out an analysis of the dossier for the medical device you have provided. We will help you to reply to all comments of the experts, obtaining a positive result gives you the right to receive a Certificate or Declaration of Conformity with the requirements of the Technical Regulations. We will help you to develop the packaging label and instructions for your medical device. We will file the necessary acquired information in the Register of persons responsible for the introduction of medical devices, active implantable medical devices and in vitro diagnostic medical devices into turnover, forms of communications, list of information kept in the Register and the access mode to such information. If your product has an EC certificate, we will help you to undergo the procedure of certificate recognition in the conformity authorities. We will carry out an audit and assist with the documentation and recommendations on how to implement corrections.