Preparing For Your First FDA or ISO Audit
Our recent blogs on preparing for your first FDA inspection and/or ISO audit generated a lot of interest, and a lot of follow-up questions from emerging med device companies all over the globe. We asked…
MDR Transition and Technical Files: What You Need to Know
Recent changes to European regulations have sparked a lot of interest and intrigue, and even more questions. So, what specifically do medical device companies need to know about these MDR and TF changes? In this…
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 a webinar addressing the first new regulations the FDA…
Software as Medical Device (SaMD) Challenges and Opportunities for 2021 and Beyond Webinar
This webinar was hosted by Andrew Wu, Branch Manager | Software Consultant at Rook Quality Systems. On December 9th, 2020, an online webinar regarding the SaMD challengers and opportunities for 2021 and beyond was hosted…