The Essential Guide to Preparing Your QMS For EU MDR
You will find this article helpful for understanding how Rook helps companies identify the critical steps needed to prepare your QMS for the upcoming EU Medical…
You will find this article helpful for understanding how Rook helps companies identify the critical steps needed to prepare your QMS for the upcoming EU Medical…
As software is progressively becoming both an integral part of many medical devices and a standalone service in the healthcare industry, manufacturers are faced with the…
This post was published by Jon Speer, the Founder and VP QA/RA at Greenlight Guru. The European Medical Device Regulation (MDR) is a new set of regulations that…
In recent years, the medical device industry has become overwhelmingly impacted by digital health. According to the US Food and Drug Administration (FDA), products that fall…
As I am sure many of you know, the ISO 13485 standard was updated in 2016, which means the time to transition your Quality Management System…