Align Agile Practices with QMS Requirements
By Allen Chen, Senior Quality Engineer at Rook Quality Systems Taiwan Branch Agile is a practical framework and an iterative approach for product development and project…
By Allen Chen, Senior Quality Engineer at Rook Quality Systems Taiwan Branch Agile is a practical framework and an iterative approach for product development and project…
The FDA recently released an Action Plan to address Artificial Intelligence/Machine Learning (AI/ML)-based Software as a Medical Device (SaMD). The action plan is based on efforts…
This post was published by Jon Speer, the Founder and VP QA/RA at Greenlight Guru. Medical devices are a big business covering a wide range of…
Currently, we are witnessing a drastic regulatory shift as MDR (2017/745/EU) replaces MDD (93/42/EEC) and AIMDD (90/385/EEC), effective May 26th, 2020. As a result, some Software…
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…
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…