Medical Device Risk Management File

The Risk Management File (FMR) is the manufacturer's documents, the purpose of which is to predict, assess and regulate the risks associated with a medical device at all stages of its life cycle.
The company "Sertigrad" is developing/correcting the Risk management File for obtaining a registration certificate for a medical device and preparing a package of documentation related to a medical device. Our specialists are ready to assist in the development/adjustment of the necessary Risk Management System according to the requirements of GOST.
The risk management file is issued in accordance with the requirements of GOST ISO 14971-2011 "Medical products.
You can apply for a service to develop a Risk Management File using the form on the main page of our website or contact our managers