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…
Importance of Software Testing on Software as Medical Device (SaMD)
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…
8 Questions about the European MDR Answered
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…
FDA’s take on Digital Health Regulatory Paradigm Shift
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…