May 29, 2019

        Currently, we are witnessing a drastic regulatory shift as MDR (2017/745/EU) replaces MDD (93/42/EEC) and AIMDD (90/385/EEC), effective May 26th, 2020. As a result, some Software as a Medical Device (SaMD) companies who already have introduced devices on the market might be subject to more stringen...

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...

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[Podcast] Implementing Changes to SaMD under new EU MDR

September 6, 2019

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