@RookQuality

Medical Device Quality Consulting

 Atlanta, GA
rookqualitysystems.com
Joined June 2015
  • Tweets440
  • Following410
  • Followers143
34Media
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
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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.
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REGISTER HERE: lnkd.in/grB-CMM

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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

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Rook Quality Systems retweeted
Ellume@EllumeHealth15 Dec 2020
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-relea…
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Rook Quality Systems retweeted
FDA Medical Devices
@FDADevices23 Nov 2020
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.
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Rook Quality Systems retweeted
FDA Medical Devices
@FDADevices16 Nov 2020
Today, the @US_FDA issued the draft guidance, Electromagnetic Compatibility (EMC) of Medical Devices – Draft Guidance for Industry and Food and Drug Administration Staff.
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Rook Quality Systems retweeted
Biolocity@Biolocity14 Oct 2020
Starting soon at 11:30am TODAY, 10/14!
Biolocity@Biolocity5 Oct 2020
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.event…. @Georgia_CTSA @ibbgatech
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Rook Quality Systems retweeted
Shawna Khouri@HeyShawnaK7 Oct 2020
"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/digi…

To maintain trust and respectability, digital health companies must commit to the highest standards

The digital health industry has been given a gift: the resources to solve the problems of health care in new ways. It's a huge opportunity and a huge responsibility. Now, in these early days, is the...

statnews.com
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Rook Quality Systems retweeted
NIH
@NIH6 Oct 2020
#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
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Rook Quality Systems retweeted
FDA Medical Devices
@FDADevices6 Oct 2020
The @US_FDA is seeking volunteers to participate in the Electronic Delivery of Premarket Submissions Pilot. This Pilot program provides a voluntary alternate method for a premarket medical device submission to CDRH during the #COVID19 public health emergency.
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Rook Quality Systems retweeted
Grace Powers@gracepowers1 Oct 2020
“A Closer Look at the FDA’s Center for Devices and Radiological Health’s Unprecedented Efforts in the COVID-19 Response” buff.ly/36lPb5c
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Rook Quality Systems retweeted
FDA Medical Devices
@FDADevices22 Sep 2020
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.
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Rook Quality Systems retweeted
FDA Medical Devices
@FDADevices11 Sep 2020
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.
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Rook Quality Systems retweeted
Paul Grand@lifesciencevc31 Aug 2020
This is a HUGE win for medical devices with FDA breakthrough designation! massdevice.com/cms-agrees-to…

CMS agrees to cover 'breakthrough' medical devices

Medicare patients will have coverage for medical devices the FDA designates as breakthrough technology under a proposed rule released this morning. Once the Medicare Coverage of Innovative Technology...

massdevice.com
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Rook Quality Systems retweeted
Grace Powers@gracepowers31 Aug 2020
“LAWFLASH HHS LIMITS FDA OVERSIGHT OF LDTS WITHOUT FORMAL RULEMAKING, INCLUDING DURING COVID-19 PANDEMIC” buff.ly/31Fixc8
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Rook Quality Systems retweeted
Eric Topol
@EricTopol27 Aug 2020
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/abbotts-5-c…
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Rook Quality Systems retweeted
Biolocity@Biolocity21 Aug 2020
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/2…
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Excited to announce that @US_FDA has granted an Emergency Use Authorization for #LumiraDx antigen test. #LumiraDx is a novel, flexible, highly scalable & low cost rapid point-of-care test that'll significantly contribute to scaling up & expanding testing platforms for #COVID19
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