Featured Posts

[Podcast] Implementing Changes to SaMD under new EU MDR

September 6, 2019

1/10
Please reload

Search

UNDERSTANDING THE NEW REQUIREMENTS FOR QMS SOFTWARE VALIDATION IN ISO 13485:2016

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 Quality Management System to comply with the new 2016 updated standard, it is time to get moving. I was recently at a client’s location helping them through their 2016 transition audit when an auditor from one of the largest notified bodies mentioned that less than 3% of their US clients are ready to transition to ISO 13485:2016…only three percent!! As a leader in the quality con

Archive
Please reload

Search By Tags

© 2020 Rook Quality Systems. All Rights Reserved. 

1155 Mount Vernon Hwy, Suite 800, Dunwoody, GA 30338