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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

Oct. 15

2027 Quality Readiness Summit by Greenlight Guru

Grace Lee, Internal Operations Manager, will join Greenlight Guru's "2027 Quality Readiness Summit" to lead the session "Internal Audits and Management Review Under QMSR: How to Think About Them Now" at 11 a.m. ET.

With FDA now able to inspect internal audit, supplier audit, and management review records, Grace will share how QA/RA teams can trace each finding through to resolution and make these activities valuable year-round, not just before an inspection.

Register for free here.

Oct. 15

Medical Device Cybersecurity: From Threat Modeling to Regulatory Readiness

RQS is teaming up with Jama Software for a webinar on medical device cybersecurity, where Allen Chen, Software Quality Manager, will share our perspective on building cybersecurity into the medical device development process.

Join us to learn how teams can manage cybersecurity risk alongside safety risk and stay ready for FDA expectations from design through submission.

Register for free here.

Oct. 18-21

AdvaMed's The MedTech Conference

Kyle Rose, Jacob Carlisle, and Joseph McGonnigal will all be representing RookQS at the industry's biggest stage, where medtech innovators, investors, and leaders gather to shape the future of healthcare. Whether you're navigating QMS, regulatory submissions, SaMD, or audit readiness, our team is ready to connect.

Find us in the partnering app and let's set up time to talk!

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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