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As noted in Part I, last week the FDA released a long-awaited updated guidance document regarding the Content of Premarket Submissions for Device Software Functions. This…
On November 4, 2021, the FDA released a long-awaited updated guidance document regarding the Content of Premarket Submissions for Device Software Functions. This guidance, the first…
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 has recently posted new guidance regarding bench testing. FDA suggests including both test report summaries and complete test reports, when appropriate. Complete test reports…
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…
The two sessions were moderated by Bakul Patel | Director for the Digital Health Center of Excellence (DHCoE) On September 22, 2020, the FDA established the…
Summary of Key Points Software development process require a variety of process planning activities that would address how you design, implement, and maintain software throughout its…
For medical device companies selling in the EU, the May 2020 deadline for Europe’s new Medical Device Regulation 2017/745 (MDR) is coming up soon. Post this…
Rook Quality Systems has always been a virtual/work from home company utilizing co-working and other tools for our business. With the COVID-19 outbreak, we wanted to…
Link to the Policy Document: https://www.fda.gov/media/136290/download As the COVID-19 situation is getting more serious all over the world, FDA issued an enforcement policy for non-invasive remote…