Darren Porras and Stuart Kozlick, RTI
MEDdesign

Intelligent Software Connectivity: An Opportunity to Transform Device Development and Health Care

By Darren Porras, Stuart Kozlick

…across intelligent applications, components, and networks. With a message-based design, complex dependencies are introduced as application software that must be developed to configure, package and send data to specific computing…

…across intelligent applications, components, and networks. With a message-based design, complex dependencies are introduced as application software that must be developed to configure, package and send data to specific computing…

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CardioMEMs sensor

Remote Monitoring Technology Improves Survival in Heart Failure Patients

By MedTech Intelligence Staff

…LAPTOP-HF trials were combined to assess the mortality and heart failure hospitalizations of 1,350 HFrEF patients. Among the three randomized trials, more than 650 patients were subjected to hemodynamic monitoring…

…LAPTOP-HF trials were combined to assess the mortality and heart failure hospitalizations of 1,350 HFrEF patients. Among the three randomized trials, more than 650 patients were subjected to hemodynamic monitoring…

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Sarah Carpenter

Medical Technology and ESG: Solving the Data Problem

By Sarah Carpenter

…accurate, complete data can overcome UFLPA detentions. The UFLPA is not the only concern. ESG and product compliance regulations are growing, and their penalties are wide-reaching. For example, per- and…

…accurate, complete data can overcome UFLPA detentions. The UFLPA is not the only concern. ESG and product compliance regulations are growing, and their penalties are wide-reaching. For example, per- and…

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European Union Flag

Clock Starts for New EU MDR Transition Dates

By MedTech Intelligence Staff

…market but not yet with the final user should be withdrawn. Only devices that comply with the previous EU law on medical devices will benefit from the extended transition period….

…market but not yet with the final user should be withdrawn. Only devices that comply with the previous EU law on medical devices will benefit from the extended transition period….

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Philip Remedios and Irina Samkova

How a Comprehensive UX Approach Brings Value to the Design Process

By Irina Samkova, Philip Remedios

…A common misconception is that UX is only about making the device interface easy to use. UX embodies numerous issues that impact design considerations. It is a complete ecosystem that…

…A common misconception is that UX is only about making the device interface easy to use. UX embodies numerous issues that impact design considerations. It is a complete ecosystem that…

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Steve Silverman
Soapbox

What You Need To Know About FDA Remote Medical Device Inspections

By Steven Silverman

…The remote inspection argument was especially compelling in the throes of Covid-19, which ground live inspections to a halt. Last year, Congress agreed. It included language in the Food and…

…The remote inspection argument was especially compelling in the throes of Covid-19, which ground live inspections to a halt. Last year, Congress agreed. It included language in the Food and…

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Pixabay Globe
From The Editor's Desk

Regulatory Intelligence: Meeting the Demands of Todayā€™s Global Regulatory Market

…and operations, quality, compliance, clinical operations, safety and surveillance, manufacturing, supply chain, medical affairs and commercial compliance. His domestic and international regulatory experience includes developing new product regulatory strategies, health…

…and operations, quality, compliance, clinical operations, safety and surveillance, manufacturing, supply chain, medical affairs and commercial compliance. His domestic and international regulatory experience includes developing new product regulatory strategies, health…

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Chris Talbot
Soapbox

The Importance of High-Quality Communication in the Healthcare Setting

By Chris Talbot

…priorities, especially when it comes to budget considerations, and both national and privately owned medical facilities are finding that Unified Communications (UC) can play a key role in improving both…

…priorities, especially when it comes to budget considerations, and both national and privately owned medical facilities are finding that Unified Communications (UC) can play a key role in improving both…

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Elijah Wreh

New Resource Sheds Light on FDA CDRH Regulatory Focus

By MedTech Intelligence Staff

…my work for Boston Scientific, I sit on the FDA advisory committee for industry and teach medical device regulation courses at two universities: Northeastern in Boston and the University of…

…my work for Boston Scientific, I sit on the FDA advisory committee for industry and teach medical device regulation courses at two universities: Northeastern in Boston and the University of…

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Peter Muller

E-labeling: The Road to Reduced Medical Device Packaging Material

By Peter Muller

…and monitor these on an ongoing basis. Finally, communicate and celebrate all wins to sustain momentum. The explosion of e-commerce and mobile device use shows how quickly and dramatically shifts…

…and monitor these on an ongoing basis. Finally, communicate and celebrate all wins to sustain momentum. The explosion of e-commerce and mobile device use shows how quickly and dramatically shifts…

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