June 5, 2019

You will find this article helpful for understanding how Rook helps companies identify the critical steps needed to prepare your QMS for the upcoming EU Medical Device Regulations in 2020. 

Link to the Article: https://www.greenlight.guru/blog/qms-eu-mdr

The European Medical Device Regulation (EU MDR) has been created to r...

May 3, 2019

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 critical steps needed to prepare your QMS for the upcoming EU Medical Device Regulations in 2020. 

The in-depth webinar will cover some of the most import...

December 13, 2018

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 regulation. Specifically this webinar will cover: 

- Upcoming changes in ISO 13485 and 21 CFR 820 to mee...

June 20, 2018

Link to the podcast:

https://soundcloud.com/medical-device-podcast/tips-tricks-best-practices-for-complying-with-iso-134852016

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, maybe you just don’t know what you need to do....

March 25, 2018

As I am sure many of you know, the ISO 13485 standard was updated in 2016, which means the time to transition your Quality Management System is now!

Most auditing organizations have either cut off ISO 13485:2003 recertifications or are doing so very soon. So, if you have not started the process of transitioning your Quali...

September 15, 2017

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 single quality management system audit that meets the requirements of all participating Regulatory A...

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[Podcast] Implementing Changes to SaMD under new EU MDR

September 6, 2019

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