Technical documentation gives the evidence, that a medical device meets the general safety and performance requirements. Technical documentation must comply with the requirements of the authorities in order to obtain CE conformity for their medical device.Sertigrad offers his services to creat Technical documentation for your medical device in order to comply with the Medical Device Regulation in Russian market.
Our services includes ;
1) Technical conditions/Technical file
2) Instructions for use/operating manual
3) Risk management file
4) Operation Manual
5) Risk management file for a medical device, etc
our experts will develop/ create the necessary documents for you, issue an application for registration of a medical device, prepare an appeal to the Federal Service for Supervision in the Field of Healthcare or help to amends during the registration of a medical device.
To clarify the full list of documents being developed, our services and cost, you can send an application or contact our manager.