Signiﬁcant changes in the Medical Device Regulation and their Implication for Manufacturers
It is important to note that the Regulation has binding legal force throughout the EU and becomes effective simultaneously in all the Member States.
Conformance with the MDR is a significant business challenge that must be overcome in order to enjoy continued access tothe EU market. To meet this challenge manufacturers must be proactive and begin preparing now.
Vigilance and Post Market Surveillance (PMS)
Manufacturers need to review their procedures for PMS and ensure that the responsibility for the provision of this additional data and associated support is clearly established.
Executive support and proactive programme management of MDR implementation is a prerequisite for a manufacturer’s success in this regard.
Scope of «VigilanX»
View your top risks, management actions and graphs in the snapshot dashboard view
Quickly identify and report on all your data security risks in time
Conduct data protection impact assessments easily and consistently
Demonstrate your compliance efforts with fast and comprehensive reporting
At the customer’s premises
Field staff can record complaints (iPhone Plus or iPad) directly at the customer’s premises, take pictures and log them by using VigilanX-WEB
Meet The Ultimate Team
A Part of our staff is at your disposal
What our customers say
The complexity is extremely well implemented
The separation between headquarters and branches is optimally solved with the two separate modules