RDC 270/2019 Summary

RDC 270/2019 Summary

Changes for Low Risk Devices in Brazil As of May 2019, there will be a new registration notification pathway allowing medical device manufacturers to access the Brazilian market quicker. The recently published RDC 270/2019 establishes this new notification pathway...
Calling all Consultants!

Calling all Consultants!

Are you a regulatory affairs consultant looking to expand your service offerings to your existing clients and increase your client base?   Arazy Group is opening Licensale for consultants in the medical and IVD device industry who wish to develop their practice....
FDA Series- SyntheticMR

FDA Series- SyntheticMR

With the MRI Systems market to reach $7.9 billion by the year 2023 and the USA being the biggest market for MRI globally, it was essential that SyntheticMR received FDA clearance for their post-processing MRI software, SyMRI (versions 10 and 11). The SyMRI...