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.
How To Prepare For Your First ISO Audit
Overview of ISO 13485:2016 ISO 13485:2016 is the industry standard for quality management systems for medical devices. Medical device specification developers, manufacturers, and distributors seek certification to ISO 13485:2016 for many reasons. Whether your organization…
What Should (and Shouldn’t) Go In a Technical File for MDR?
European regulations require manufacturers to create and maintain a technical file as a prerequisite to submitting a Declaration of Conformity, allowing products to be CE marked. If you’re like a lot of med device companies…
FDA’s ISO 13485 Transition Plan … What Does it Mean for Your Medtech’s Quality Plan?
In this episode of the Project Medtech Podcast, Rook Founder/President Kyle Rose and Duane Mancini discuss in detail the FDA’s ISO-13485 transition plan, when it was announced, what it looks like, the differences 21 CFR…