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…
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…
You will find this article helpful for understanding how Rook helps companies identify the critical steps needed to prepare your QMS for the upcoming EU Medical…
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…