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…
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…
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…
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…
Understanding the Medical Device Single Audit Program and How to Prepare for it
This webinar was hosted by Kyle Rose, the President of Rook Quality Systems. You will find this webinar helpful for preparing the registration process with MDSAP…
How to Conquer Supplier Management for Medical Device Companies
This webinar was hosted by Kyle Rose, the President of Rook Quality Systems. You will find this webinar helpful for understanding purchasing and supplier control process…
Preparing your QMS for EU MDR
This webinar was hosted by Kyle Rose, President of Rook Quality Systems. You will find this webinar helpful for understanding how Rook helps companies identify the…
Key Considerations for SaMD Companies Developing and Commercializing Software as Medical Devices
This webinar was hosted by Andrew Wu, Branch Manager | Software Consultant at Rook Quality Systems. You will find this webinar helpful for understanding how Rook…