Rook Quality Systems

448 posts

Rook Quality Systems banner
Rook Quality Systems

Rook Quality Systems

@RookQuality

Medical Device Quality Consulting

Atlanta, GA 参加日 Haziran 2015
415 フォロー中144 フォロワー
Rook Quality Systems がリツイート
Tulsa Innovation Labs
Tulsa Innovation Labs@tulsainnovation·
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
Tulsa Innovation Labs tweet media
English
0
2
7
0
Rook Quality Systems
Rook Quality Systems@RookQuality·
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.
Rook Quality Systems tweet media
English
1
0
0
0
Rook Quality Systems
Rook Quality Systems@RookQuality·
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
English
0
0
0
0
Rook Quality Systems がリツイート
Dr. Stephen M. Hahn
Dr. Stephen M. Hahn@SteveFDA·
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…
English
0
10
16
0
Rook Quality Systems がリツイート
FDA Medical Devices
FDA Medical Devices@FDADeviceInfo·
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.
English
1
6
5
0
Rook Quality Systems がリツイート
FDA Medical Devices
FDA Medical Devices@FDADeviceInfo·
Today, the @US_FDA issued the draft guidance, Electromagnetic Compatibility (EMC) of Medical Devices – Draft Guidance for Industry and Food and Drug Administration Staff.
FDA Medical Devices tweet media
English
1
2
2
0
Rook Quality Systems がリツイート
NIH
NIH@NIH·
#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
English
1
34
28
0
Rook Quality Systems がリツイート
FDA Medical Devices
FDA Medical Devices@FDADeviceInfo·
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.
English
1
2
2
0
Rook Quality Systems がリツイート
Grace Powers
Grace Powers@gracepowers·
“A Closer Look at the FDA’s Center for Devices and Radiological Health’s Unprecedented Efforts in the COVID-19 Response” buff.ly/36lPb5c
Grace Powers tweet media
English
0
1
1
0
Rook Quality Systems がリツイート
FDA Medical Devices
FDA Medical Devices@FDADeviceInfo·
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.
FDA Medical Devices tweet media
English
2
28
55
0
Rook Quality Systems がリツイート
FDA Medical Devices
FDA Medical Devices@FDADeviceInfo·
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.
English
0
10
19
0
Rook Quality Systems がリツイート
Grace Powers
Grace Powers@gracepowers·
“LAWFLASH HHS LIMITS FDA OVERSIGHT OF LDTS WITHOUT FORMAL RULEMAKING, INCLUDING DURING COVID-19 PANDEMIC” buff.ly/31Fixc8
Grace Powers tweet media
English
0
1
0
0
Rook Quality Systems がリツイート
Eric Topol
Eric Topol@EricTopol·
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…
Eric Topol tweet media
English
30
278
806
0