Blog

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…