The new Medical Device Regulations (MDR)
were published in 2017 and the clock is now
ticking for manufacturers to meet these
We can help your organization meet
these new requirements.
Review your product portfolio to determine if there are any changes to the classification or the conformity assessment routes
Review your technical files or design dossier against the new Safety and Performance requirements
Identify the gaps
Implement plans and solutions to remediate your technical files/design dossiers.
Successfully obtain a CE mark for the new MDR