Move Count
Getting a medical device to market is an amazingly complex challenge; not unlike a game of tournament chess. You need the optimal strategy and tactics to manage all the moving parts. With Rook, you’re partnering with a grandmaster to ensure that you never make a wrong move that could set your approval back months (or years).
We leverage a decade of experience, expertise, and established best practices to build customized QMS so you can get your devices to market significantly faster than standard industry methods.
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 a plethora of great content, as well as information on our growing team, and easier access to RookQS resources. We thought we’d highlight some of the growth over the past ten years with this blog.
Steps the FDA Continues to Take to Strengthen the Premarket Notification [510(k)] Program
Last week, the U.S. Food and Drug Administration (FDA) released three new draft guidances to strengthen the 510(k) program and to advance the safety and effectiveness of medical devices. A 510(k) is a premarket submission…
What To Do (And What Not To Do) When You Receive a FDA Audit Notice
Receiving an audit notice from the FDA can be a daunting experience, but it also presents a great opportunity for your medical device company to demonstrate its commitment to patient safety and regulatory compliance. By…
Risk Management in the Medical Device Industry – Part 2
ISO 14971 and ISO 24971: Enhancing the Safety of Medical Devices through Effective Risk Management The development and manufacturing of medical devices are critical processes that require strict adherence to safety standards to protect patients…