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Events, Podcasts, and Webinars

Stay connected with RookQS across the MedTech community, from live events to on-demand insights.

On-Demand Webinars

Check out our webinars to get actionable insights in the MedTech community. Click below to see the full list of on-demand webinars.


Upcoming Events

May 28th

Handling Audits Around the QSR to QMSR Transition

Molly Layne, Audit Manager at Rook Quality Systems, is joining a Greenlight Guru webinar to walk through how audits are evolving under QMSR, where legacy QSR documentation tends to fall short, and what a well-prepared manufacturer should have in place before an auditor walks in the door.

Learn more and register here

June 5th

Webinar: The Arc of Agile Medical Devices

Glassboard CEO, Grant Chapman, is sitting down with Kyle Rose, CEO and Founder of Rook Quality Systems, for a practical conversation on building smarter under ISO 13485.

Learn more and register here

June 10th

APACMed Supply Chain Summit Asia-Pacific 2026

Andrew Wu, VP of Medical Software & General Manager, APAC at Rook Quality Systems will be providing his expertise on two panels: "Designing Future-Proof Supplier Networks Through Strategic Risk Management" and "From Data to 
Decisions – Driving ROI Through Digital Transformation in MedTech 
Supply Chains".

Learn more and register here

June 17th

Webinar: Wearable and Home-use Devices Part 2: FDA Submissions

In a webinar hosted by Medmarc, Tyler Ting, Director of Regulatory at Rook Quality Systems, will walk you through the FDA submission landscape specific to wearable and home-use devices, so you can move from development to clearance with confidence.

Learn more and register here

Podcast Appearances

FDA’s ISO 13485 Transition Plan … What Does it Mean for Your Medtech’s Quality Plan?
April 27, 2022
LISTEN NOW In this episode of the Project Medtech Podcast, Rook Founder/President Kyle Rose and Duane Mancini discuss in detail the FDA’s ISO-13485 transition plan, when it was announced, what it looks like, the differences 21 CFR Part 820 vs....
Tips, Tricks, and Best Practices for Complying with ISO13485:2016
November 05, 2020
LISTEN NOW 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. You are not alone because a lot of...
What are the regulatory expectations for Software as a Medical Device (SaMD)?
November 05, 2020
LISTEN NOW 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 companies ensure that their documentation, platform, and systems they...
Implementing Changes to SaMD under new EU MDR
October 11, 2020
LISTEN NOW Hosted by Andrew Wu of Rook Quality Systems, this podcast will help you understand changes imposed on SaMD under new EU MDR. SaMD manufacturers will benefit from clarifications on qualification and classification changes and action...

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