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…
Summary of Key Points Software development process require a variety of process planning activities that would address how you design, implement, and maintain software throughout its…
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…
When it comes to 13485-2016, are you scrambling to meet requirements? Are you trying to figure out the how, what, or when regarding its timeline? Or,…
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…
This podcast was hosted by Andrew Wu, the Software Consultant of Rook Quality Systems. You will find this podcast helpful for understanding how Rook helps SaMD…
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…
For medical device companies selling in the EU, the May 2020 deadline for Europe’s new Medical Device Regulation 2017/745 (MDR) is coming up soon. Post this…
Rook Quality Systems has always been a virtual/work from home company utilizing co-working and other tools for our business. With the COVID-19 outbreak, we wanted to…
Link to the Policy Document: https://www.fda.gov/media/136290/download As the COVID-19 situation is getting more serious all over the world, FDA issued an enforcement policy for non-invasive remote…