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Rook Quality Systems Founder and CEO, Kyle Rose, led a live webinar session on November 6th focusing on three recent FDA regulatory updates. The following three topics were discussed: FDA Draft Guidance on the Chemical Analysis of Biocompatibility Assessment for Medical Devices, FDA's recent recognition of three international sterilization standards, and the LDT Final Rule Stage 1 compliance re...

This webinar was recorded live on August 29th, 2024. Experts Kyle Rose (Rook Quality Systems), Axel Strombergsson (QuickVault), and Jeff Hau (QuickVault) discussed the essential components of Design Verification and Validation (DV&V) in medical device development.

This webinar was presented live on July 25th, 2024, hosted by Rook Quality Systems and QuickVault by Veeva Systems. Kyle Rose (RookQS), Axel Strombergsson (Veeva), and Jeff Hau (Veeva) led the session, discussing best practices for developing and implementing design controls. Kyle outlined FDA and ISO guidelines, stressing the importance of early identification of test plans, particularly for s...

This webinar was hosted by Rook Quality Systems in collaboration with Digital Scientists. The live webinar was held on June 20th, 2024. This session covered the app development process, product blueprints, importance of user-centric design, determining product classification, premarket pathways, predicate devices, and the significance of early identification of testing requirements.

Choosing, buying and implementing an eQMS can be an intimidating and difficult process, from identifying the needs of your organization to evaluating vendors to developing a business case. And then comes implementation - it can take a lot of time and effort - but it doesn’t have to. Join Rook Quality Systems and ETQ, part of Hexagon, to learn how you can make this process as easy and efficient ...

This session explores the hurdles encountered by start-up medical device companies as they navigate regulatory requirements. Understanding where to initiate your journey towards regulatory compliance can feel daunting and oftentimes presents a significant challenge. Empower your MedTech startup's journey to regulatory compliance with QuickStart. This webinar took place on May 30th, 2024. The we...

The live webinar took place on May 15th, 2024. The webinar was led by Rook Quality System's VP of Medical Software, Andrew Wu, and Ketryx's VP of Client Operations, Jake Stowe.

Presented by Rook Quality System's VP of Medical Software, Andrew Wu on October 26th, 2022.

This webinar was presented on March 28th, 2024 by Andrew Wu from Rook Quality Systems and Abbas Dhilawala from Galen Data. The webinar was moderated by Jaclyn Maney from Rook Quality Systems.

Presented by Chandler Thames, Director of Quality, on February 6th, 2024.