MedAware Systems
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MedAware Systems, Inc. Human clinical trials are the basis of evidence-based medical science and treatment.
disrupts the health informatics industry by forever changing the way Pharma and medical device companies, physicians, payers and patients derive usable evidence from published clinical trials research. disrupts the health informatics industry by forever changing the way physicians, researchers, payers and consumers derive usable, accurate evidence from published clinical trials research. The resul
MedAware Systems announced today a major expansion of Neuromodulation device data in its SOHInfo (www.sohinfo.com) customer portal. The portal is populated with reported data from registries, published literature, and social media for all registered devices for Spinal Cord Stimulation, Peripheral Nerve Stimulation, Ganglia Dorsal Root Stimulation, RF Ablation, Parkinson - Deep Brain Stimulation, Sacral Stimulation – Incontinence, and others. Global regulatory reported data is provided on all manufacturers’ products for each product class. Learn more at:https://medawaresystems.com/wp-content/uploads/2021/12/MedAware-Systems-Expands-Post-Market-Surveillance-for-Neuromodulation-Devices.pdf
08/31/2021
https://futurology.life/101-most-innovative-colorado-based-artificial-intelligence-companies/
Proud to be recognized as a leading company focusing on AI in healthcare. Our Advanced Intelligence application combines both AI and HI (Human Intelligence) to assemble massive data sets that deliver unprecedented levels of evidence on the safety and efficacy of medical treatments and devices.
101 Most Innovative Colorado Based Artificial Intelligence Companies This article showcases our top picks for the best Colorado based Artificial Intelligence companies. These startups and companies are taking a variety of approaches to innovating the Artificial Intelligence industry, but are all exceptional companies well worth a follow. We tried to pick companies
MedAware Systems Launches Automated Post Market Surveillance for Closure Devices
We've added another product group to our AI-powered SOHInfo Post Market Surveillance service. We are completing the service to cover all Class III and Class IIA devices. Learn more at :https://medawaresystems.com/wp-content/uploads/2021/07/MedAware-Systems-Launches-Automated-Post-Market-Surveillance-for-Closure-Devices.pdf
07/06/2021
This Opinion from the EC reinforces the importance of comprehensive data for MDR submissions. The cost, in terms of time and effort, to resubmit can be significant, making "getting it right" the first time a priority. To see how MedAware Systems solves this problem, please visit www.medawaresystems.com.
https://lnkd.in/eQJRWcx
Clinical Trials Data | Medaware Systems Maximizing value from clinical trials research for Pharmaceutical and Medical Device Companies, Physicians, Payers, and Patients
Post Market Surveillance for Catheter Introducers
We are pleased to announce the release of this new product group for our post market surveillance and product monitoring service.
For details, please see:
In the absence of the European database on medical devices (EUDAMED), a series of clinical investigation application/notification documents have been created to support clinical investigation procedures with respect to MDR. These documents include: Clinical investigation – application/notification form under the MDR; Addendum to the clinical investigation application/notification form for various devices and sites; and Clinical investigation supporting documents.
Also included is an Appendix of documents to attach, Checklist of general safety and performance requirements, Standards, common specifications and scientific advice. Learn more at:https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-8_en.pdf
MedAware Systems Releases Cross-Platform Post Market Product Monitoring Service.
MedAware Systems announced the release today of its Science of Health Informatics (SOHInfo) cross-platform monitoring and surveillance management service. The AI-powered subscription application provides continuous monitoring and analysis on reported Adverse Events, Published Scientific Literature, and reported events on major Social Media platforms - keeping round-the-clock vigilance of pharmaceutical and medical device products.
Learn more at: https://lnkd.in/e2G-77u device
04/23/2021
New MDCG 2021-6 on Clinical Investigations
The Medical Device Coordinating Group (MDCG) published new guidance on clinical investigation and evaluation. The document offers useful summaries on how clinical investigations are defined and on performance and benefits reporting.
https://www.linkedin.com/pulse/new-mdcg-2021-6-clinical-investigations-wiebe-postma/?trackingId=UxfjQUqWWVLmnmDK9nx1Tg%3D%3D
New MDCG 2021-6 on Clinical Investigations Published: April 23, 2021. Yesterday (22 April) the Medical Device Coordinating Group (MDCG) published a new guidance in the category of clinical investigation and evaluation: MDCG 2021-6 “Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation”. This important ...
04/07/2021
From the article: "The MDR puts a higher emphasis on clinical data for medical devices and calls for increased scrutiny on the duty of manufacturers to continuously collect clinical data in the postmarket setting. Manufacturers are required to proactively collect and evaluate clinical data on the use of their devices."
Instantly and continuously delivering clinical data and postmarket data (including from social media) is the core of our Complete Product Monitoring System. See more at www.sohinfo.com
https://lnkd.in/eJKEqGg
How To Navigate Clinical Data Per EU MDR The EU MDR puts a higher emphasis on clinical data for medical devices and calls for increased scrutiny on the duty of manufacturers to continuously collect clinical data in the postmarket setting. Matthias Fink, MD, of TÜV SÜD America explains the MDR requirements surrounding clinical....
03/12/2021
An excellent article discussing the various requirements for class II and III device certification. MedAware Systems' Advanced Intelligence Surveillance and Data Services are purpose-built to rapidly and comprehensively address these requirements.
Advanced Intelligence is the unique combination of Artificial and Human Intelligence that saves considerable time, effort, and cost in the development of CER's and ongoing post market surveillance.
https://www.linkedin.com/posts/michael-willis-a5625585_ai-surveillance-data-activity-6776181803892977664-ENY1
MedAware Systems’ Science of Health Informatics (SOHInfo) announces a major upgrade of its medical device surveillance service to include reporting on social media posts.
This new functionality supports both FDA and MDR post market vigilance requirements. Learn more at:
If you have not seen this guidance, it provides important information on the conduct and reporting of clinical investigations prior to the finalization of EUDAMED. Administrative practices and alternative technical solutions for the exchange of information until EUDAMED is fully functional is described.
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2525 Arapahoe Avenue, E4/196
Boulder, CO
80302