FDA Digital Health Center of Excellence Listening Sessions
The two sessions were moderated by Bakul Patel | Director for the Digital Health Center of Excellence (DHCoE) On September 22, 2020, the FDA established the…
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…
Software Development Process for Healthcare Applications
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…
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…
Tips, Tricks, and Best Practices for Complying with ISO13485:2016
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,…
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…
What are the regulatory expectations for Software as a Medical Device (SaMD)?
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…
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…
Documentation impacted by EU MDR
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…
Medical Device QA – Work From Home Tips
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…