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…
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 program, which allow medical device manufacturers to have a…
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 detailed in the ISO 13485/ 21 CFR820/ MDSAP/ MDR…