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…
Link to the Policy Document: https://www.fda.gov/media/136939/download The FDA recently put out a new enforcement policy for digital health devices treating psychiatric disorders during the COVID-19 Public…
After 8 years of establishment, Rook Quality System has officially launched its first international branch office in Taiwan. The new branch office will open new opportunities…
Summary of Key Point The key to address medical device software regulation starts with three questions: What does your software do? How do you plan to…
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…