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…
Rook Quality Systems: Celebrating a Decade of Gratitude and Growth
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…
5 BOLD Predictions for Medical Device Quality in 2022
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…
‘Tis the Season … for an Internal Audit
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…
Rook QS Webinar: First FDA Software Updates in 16 Years
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…
At Long Last: FDA Updates Software Guidance (Part II of II)
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…
At Long Last: FDA Updates Software Guidance (Part I of II)
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…
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…