Rook Quality Systems @RookQuality
Medical Device Quality Consulting rookqualitysystems.com Atlanta, GA Joined June 2015-
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Sneak peek at our virtual health white paper. Sahee and Shawna have been working hard to share our thoughts on what the future of predictive health analytics looks like. We can’t wait to share the final paper with you! #ai #digitalhealth
Ready to learn how to use risk management as a tool to design safer medical devices? We’re a proud sponsor of the Risk Management True Quality Summit Series, coming live to you June 24th. Our own Sarah Nixon is diving into the importance of Hazard Analysis in ISO 147971:2019.
Five action items to address Artificial Intelligence/Machine Learning- based SaMD and help with providing clear guidance to developers on how to prioritize patient safety while still utilizing this transformative technology. lnkd.in/d2XRh5V #SaMD #QMS #medicaldevices
Have questions about EU IVDR/MDR? Please join RookQS on March 15th at 10am (EST) to hear Kyle Rose speak about the upcoming IVDR challenges and opportunities for 2021 and beyond. lnkd.in/d57bgex #qms #qualitysystems #ivdr #mdr
Together with CDRH Director Dr. Jeff Shuren, I wrote a piece highlighting significant diagnostic achievements over the last year: 300+ EUAs, that's nearly one test every day during this public health emergency. @FDADeviceInfo medscape.com/viewarticle/94…
BREAKING: Ellume’s over-the-counter, at-home, 15-minute #COVID19 antigen test receives @US_FDA Emergency Use Authorization. The first OTC fully at-home #rapidtest. No prescription required. globenewswire.com/news-release/2…
The @US_FDA released three videos highlighting patients’ experiences in partnering with the FDA and how patient input enhances the agency’s ability to evaluate medical devices and monitor their safety. Check out the videos.
Today, the @US_FDA issued the draft guidance, Electromagnetic Compatibility (EMC) of Medical Devices – Draft Guidance for Industry and Food and Drug Administration Staff.
Starting soon at 11:30am TODAY, 10/14!
Want to learn networking and team-building tips for your life science #startup? Join our October 14th #Bench2MarketTalk hosted by @kirklbarnes. Free registration at b2mbuildingstartupteam.eventbrite.com. @Georgia_CTSA @ibbgatech
"We may one day look back on this moment and say, 'That’s when the digital health transformation became real.'" #virtualhealth #digitalhealth @tulsainnovation statnews.com/2020/10/07/dig…
#NIH & @BARDA award $98.35M for scale-up & manufacturing of 6 additional #COVID19 testing technologies, the 3rd set of technologies from #RADx. Novel approaches include smart-device integration, mobile-lab processing for virus hot spots, & more: bit.ly/33yRD6s
“A Closer Look at the FDA’s Center for Devices and Radiological Health’s Unprecedented Efforts in the COVID-19 Response” buff.ly/36lPb5c
Today, the @US_FDA launched the Digital Health Center of Excellence (DHCoE.) The DHCoE seeks to empower digital health stakeholders to advance healthcare by fostering responsible and high-quality digital health innovation.
Today @US_FDA provided market authorization for another ECG mobile app to be used OTC with a consumer wearable device--adding Fitbit to the list of manufacturers--Apple & Samsung--who provide this #DigitalHealth technology to help consumers be more engaged in their health.
This is a HUGE win for medical devices with FDA breakthrough designation! massdevice.com/cms-agrees-to-…
“LAWFLASH HHS LIMITS FDA OVERSIGHT OF LDTS WITHOUT FORMAL RULEMAKING, INCLUDING DURING COVID-19 PANDEMIC” buff.ly/31Fixc8
A + feature in the new $5 antigen test "uses lateral flow technology similar to a home pregnancy test and can be linked to a mobile-phone app that gives an all-clear code... test negative at work or school" Needs to be incorporated in home tests in future wsj.com/articles/abbot…
Announcing the 5 faculty-lead #innovations selected to participate in the newest cohort of Biolocity Launch! We look forward to supporting these patient-impacting technologies through their #commercialization milestones. sites.gatech.edu/biolocity/2020…
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