authority legislation
Introduction
Does your QMS need an update, to be compliant to MDR and MDSAP?
We are experts in authority legislation for medical devices, so whether you need help classifying your medical device or interpret the requirements for submission of documentation, or any other task regulated by authorities, we can help you.
EU MDR
Detailedknowledge of the new Medical Device Regulation. We know the difference between the MDD and the MDR and we have performed several Gap analyses ensuring QMS compliance.
US FDA
Long hands–on experience with the FDA Regulation and approval process for medical devices and combination products.
MDSAP
Practical experience with certification according to MDSAP. We know the Notified Bodies’ expectations to your documentation.
cGMP
Detailed experience with interpretation of cGMP requirements. We know how to transfer the theoretical requirements into practice in an organization.