5 BOLD Predictions for Medical Device Quality in 2023
With the new year upon us, we asked our Founder/President, Kyle Rose, and our General Manager (Taiwan Branch), Andrew Wu, to peer into their respective crystal…
With the new year upon us, we asked our Founder/President, Kyle Rose, and our General Manager (Taiwan Branch), Andrew Wu, to peer into their respective crystal…
March 2022 is a momentous time for RookQS, as it officially marks our ten-year anniversary as a company. To celebrate, we’ve launched a new website with…
In our upcoming webinar for emerging medical device companies, we will elaborate on these five bold prophecies, enabling you to peer into our crystal ball and…
As the end of the year rapidly approaches, many companies are rushing to get their internal audits completed before 2022. The internal audit process is critical…
On Monday, November 22nd, Rook's Kyle Rose and Andrew Wu, two of the industry's foremost experts on quality and regulatory strategy in the software space, presented…
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…
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…