Blog
FDA Digital Health Center of Excellence Listening Sessions
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…
Software Development Process for Healthcare Applications
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…
Documentation impacted by EU MDR
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…
Medical Device QA – Work From Home Tips
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…
Enforcement Policy from the FDA to combat COVID-19
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…
Enforcement Policy — Digital Health Devices For Treating Psychiatric Disorders During COVID-19
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…
Rook Quality System Announces Taiwan Branch Office
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…
The Essentials: Regulatory requirements for medical device software
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…
What is Software as a Medical Device (SaMD)?
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…
Classification and Qualification of SaMD under MDR
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…