This webinar was hosted by Andrew Wu, Branch Manager | Software Consultant at Rook Quality Systems. You will find this webinar helpful for understanding how Rook…
Link to the Policy Document: https://www.fda.gov/media/136290/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…
Hosted by Andrew Wu of Rook Quality Systems, this podcast will help you understand changes imposed on SaMD under new EU MDR. SaMD manufacturers will benefit…
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…
This is Part 2 of a two-part series focusing on FDA’s Pre-Cert Working model. 4. Streamlined Review: It is expected that software products that are considered…
The Pre-Cert program represents a new regulatory paradigm for FDA regulating future software as medical device (SaMD). To cope with shorter development cycles and unique opportunities…
If you are currently selling or are looking to sell a medical device in Europe, you should have heard about the big industry news: the European…