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MedAware Systems @MedAwareSystems

MedAware Systems, Inc. empowers Pharma and Medical Device companies with all available evidence from published literature, event databases, and social media.

Joined February 2015
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I will be at CTAD next week in my role as the new Vice President for Business Affairs at Biomed Industries. Hoping to connect with colleagues at the event to explore collaborating on our Phase 3 trial for Biomed's breakthrough Alzheimer's therapy
MedAware Systems Expands Neuromodulation Device Regulatory Data Portal. Learn more at: medawaresystems.com/wp-conte…
futurology.life/101-most-inn… Proud to be recognized as a leading company focusing on AI in healthcare. Our Advanced Intelligence application combines AI and HI (Human Intelligence) to deliver unprecedented levels of evidence on the safety and efficacy of medical treatments and devices
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 ec.europa.eu/health/sites/de… #medicaldevices #clinical #compliance #research
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MedAware Systems announces that its Science of Health Informatics (SOHInfo) Post Market Surveillance Service for Cervical Disc Replacement devices is now available. Learn more at: lnkd.in/eGQQxUR #postmarketsurveillance #artificialintelligence #fda #eumdr
MedAware Systems’ Science of Health Informatics (SOHInfo) announces a major upgrade of its medical device surveillance service to include reporting on social media posts. medawaresystems.com/wp-conte…
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. ec.europa.eu/health/sites/he…
May 26, 2022 is the deadline for IVDR technical documentation on post-market surveillance. To learn how to obtain all available data in the timeliest and most cost-effective way possible, visit sohinfo.com
As the blog post points out, device manufacturers need to focus on post-market reporting, traceability, and technical documentation. Intelligent post market software is key. assurx.com/eu-mdr-compliance…

EU MDR Compliance Check-in: Challenges and Action Items | AssurX

The new EU Medical Device Regulation (MDR) goes into effect in less than six months, leaving little time for medical device manufacturers to bring products into compliance. The new law represents a...

assurx.com
MedAware Systems’ Science of Health Informatics (SOHInfo) announces the launch of its comprehensive AI-powered surveillance service for Spinal Cord and Peripheral Nerve stimulation devices from all major manufacturers. medawaresystems.com/wp-conte…
The MDR requires Class IIb and class III devices to have annual safety updates. Class IIa every 2 years. Maintaining a comprehensive data set of Adverse Events, curated from the published literature, considerably reduces the time, effort, and cost. sohinfo.com
Part 2 of Jayet Moon's series on Risk-Based Postmarket Surveillance (PMS) focuses on the importance of developing a Systems approach, especially for EUMDR submissions. A must read at: lnkd.in/euN9uA7 #eumdr #ai #surveillance #healthcare #riskmanagement

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MedAware Systems Launches Drug Eluting Stent Event Surveillance. Learn more at medawaresystems.com/wp-conte…
The UK has finally left the EU: what does this mean for medtech? The UK's Medicines and Healthcare products Regulatory Agency (MHRA) will recognize CE marks until the end of June 2023. medicaldevice-network.com/fe… #healthcare #medicaldevices

The UK has finally left the EU: what does this mean for medtech?

Brexit has finally completed and the UK is no longer and EU member state - but what does this mean for the medtech industry right now?

medicaldevice-network.com
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Risk-Based Postmarket Surveillance (PMS) In The Age Of EU MDR: Risk-Based Trending Risk-based incident trending for post market signal detection is becoming an expectation from most regulatory agencies. meddeviceonline.com/doc/risk…

Risk-Based Postmarket Surveillance (PMS) In The Age Of EU MDR: Risk-Based Trending

Risk-based incident trending for postmarket signal detection is quickly becoming an expectation from most regulatory agencies and EU MDR is one of the first regulations to expressly document this...

meddeviceonline.com
MedAware Systems launches Comprehensive Structural Heart Device Surveillance for Reported Events medawaresystems.com/wp-conte…
A good article on Vigilance reporting under the MDR... citemedical.com/pms-part2/
Replication of Randomized, Controlled Trials Using Real-World Data: What Could Go Wrong? Dr. David Thompson published a thoughtful paper the topic. Dr. Zung Tran, from MedAware Systems added some additional thoughts. linkedin.com/.../detail/rece…
New FAQ on EUDAMED from the European Commission. ec.europa.eu/health/sites/he…
Notified bodies report early success with remote audits but challenges remain. medtechdive.com/news/notifie…

Notified bodies report early success with remote audits but challenges remain

While there have been benefits to going remote during the pandemic, 57% of those polled by a European trade group say they take longer than on-site assessments and most encounter problems due to poor...

medtechdive.com
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