SERVICES
EU MDR Gap Assessment
How ready are you ?
New MDR will enter into force on May 26, 2020 and will imply several key changes for medical device manufacturers who want to sell their products in Europe.
How can we help ?
The SfMEDEV consulting team which is present in UK, Europe and Switzerland offers to conduct a gap assessment of your current system against the new legislation, analyse, document and list the possible solutions.
Documentation Management
Support
Electronic documentation (eCTD) has become compulsory for european submissions since January 1st, 2019.
We provide short-term assistance to work on that interactively.
Tools
We want to help you removing ALL paper-based document management systems so that you can run automated tools to check regulatory conformities.
Regulatory affairs
CE Marking
SfMEDEV is ready to help in every aspects of the CE marking route: classification, technical file and design dossier, essential requirements, risk analysis and clinical study.
EU Representative
EU manufacturers located outside of Europe can request SfMEDEV to be their official contact with european authorities.