The first step in the process of bringing a drug or medical device to market
The first step in the process of bringing a medical device to market
The first step in the process of bringing a drug or medical device to market
The center for obtaining resolution documents "Sertigrad" helps companies to implement a quality management system (QMS) that meets industry standards for medical devices production. We cooperate with accredited laboratories in the field of technical, clinical and qualification testing, research in order to evaluate the biological effect of medical devices, in order to provide our customers with a comprehensive solution for regulating the movement of medical devices and product in the target markets of the EAEU countries.
Our experts will develop all types of documents for the customer and, if necessary, can easily make their translation and notarization.
Center "SertiGrad" has non-standard approach to each client, teamwork of employees, an impeccable reputation and a guaranteed positive result!
To get started, leave a request on the site or contact us by phone number +7 (000) 000-00-00.
You send documents with a detailed description of medical devices to our center. Our experts analyze the documents and we present you with a commercial offer for our services of medical devices registration support.
The staff of the expert department of our center creates and prepares documents for the registration of medical devices. If necessary, the documents will be translated and certified by a notary.
According to the registration rules, in EAC, all medical devices must under go laboratory testing. Laboratory testing can be technical, toxicological, clinical depending on your medical device. We will inform you which tests must be taken for your particular medical device.
After the package of documents is ready and tested, we form a registration dossier on your medical product and send it to an inspection body. The inspection body conducts an examination of the quality, efficiency and safety of the medical product. In case of formal comments, the experts of our Center interacting with you will solve this issue.
The inspection body decides on the registration of a medical product. We get the original document and transfer it to you in a convenient way for you.
