If you have more questions feel free to contact us.CONTACT US
Medalis provides assistance in the preparation/refinement of technical documentation and operational
documentation for the registration of a medical device.
High-quality technical and operational documentation prepared in compliance with applicable regulations is the most important source of information about a medical device.
The service is essential for manufacturing companies that obtain registration for their medical devices independently but lack experience in preparing certain documents.
Unfortunately, errors in documents submitted to the registering authority (the Federal Service for Surveillance of Healthcare) result in a large number of refusals and cost a huge amount of money and time. Therefore, our job is to prepare a document of the highest standards, compliant with all applicable regulatory requirements.