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FDA Issues Draft Guidance on Predetermined Change Control Plans for AI/Machine Learning-Enabled Medical Devices

By MedTech Intelligence Staff

…of the methodology that would be used to develop, validate, and implement those modifications—including describing how necessary information about these modifications will be clearly communicated to users; and an assessment…

…of the methodology that would be used to develop, validate, and implement those modifications—including describing how necessary information about these modifications will be clearly communicated to users; and an assessment…

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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

…or supplier oversight, for example, or complaint handling and adverse event reporting. Notably, this information is provided electronically (and remotely), outside a standard FDA inspection. FDA may consider the information…

…or supplier oversight, for example, or complaint handling and adverse event reporting. Notably, this information is provided electronically (and remotely), outside a standard FDA inspection. FDA may consider the information…

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Pixabay Globe
From The Editor's Desk

Regulatory Intelligence: Meeting the Demands of Today’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

…terms of how best to communicate with regulators if you do need clarity or have concerns? Wreh: In the U.S., Advamed works with most of the big device manufacturers and…

…terms of how best to communicate with regulators if you do need clarity or have concerns? Wreh: In the U.S., Advamed works with most of the big device manufacturers and…

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