Michael Earl
Soapbox

Digitalizing Drug Delivery – What’s Next?

By Michael Earl

for example, data privacy laws differ at both national and regional levels, creating barriers for companies looking to launch their products across multiple markets. Once we begin to navigate these…

for example, data privacy laws differ at both national and regional levels, creating barriers for companies looking to launch their products across multiple markets. Once we begin to navigate these…

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Brad Jolly
MEDdesign

Five Critical Considerations for Connected Health Manufacturers

By Brad Jolly

…on-board security controls and crash, deadlock, or freeze a device. To combat these threats, device manufacturers must implement a comprehensive testing mechanism called protocol fuzzing. The process injects various errors…

…on-board security controls and crash, deadlock, or freeze a device. To combat these threats, device manufacturers must implement a comprehensive testing mechanism called protocol fuzzing. The process injects various errors…

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3M logo

3M Health To Collaborate with Amazon To Accelerate AI in Clinical Documentation

By MedTech Intelligence Staff

…3M will use AWS Machine Learning (ML) and generative AI services, including Amazon Bedrock, Amazon Comprehend Medical and Amazon Transcribe Medical, to help expedite and scale the delivery of 3M’s…

…3M will use AWS Machine Learning (ML) and generative AI services, including Amazon Bedrock, Amazon Comprehend Medical and Amazon Transcribe Medical, to help expedite and scale the delivery of 3M’s…

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Wiktoria Banczyk
MEDdesign

Ask the Expert: The Impact of IVD Regulations on Manufacturing

…devices, as it requires manufacturers to comply with new and more rigorous regulatory requirements. Manufacturers must ensure that their devices meet the new safety and performance requirements, establish a quality…

…devices, as it requires manufacturers to comply with new and more rigorous regulatory requirements. Manufacturers must ensure that their devices meet the new safety and performance requirements, establish a quality…

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Michael Keer

Selecting a Resilient Medical Device Contract Manufacturer for Long-term Success

By Michael Keer

…earthquakes, floods, or hurricanes. Regulatory Compliance Medical device OEMs operate in a heavily regulated environment, and compliance with requirements is critical to success. Therefore, the CM should have a comprehensive…

…earthquakes, floods, or hurricanes. Regulatory Compliance Medical device OEMs operate in a heavily regulated environment, and compliance with requirements is critical to success. Therefore, the CM should have a comprehensive…

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Sanobar Syed

Three Steps to Gain the Full Advantage of Pharmaceutical Business Forecasting

By Sanobar Syed

…is a new launch, predictive modeling might not be feasible due to the incompleteness of data. In this case, market research and competitive intelligence will be preferred (if it is…

…is a new launch, predictive modeling might not be feasible due to the incompleteness of data. In this case, market research and competitive intelligence will be preferred (if it is…

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FDA Logo

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

By MedTech Intelligence Staff

…including software functions that are part of or control hardware medical devices,” said O’Leary. Stakeholders can submit comments on the draft guidance and download the full draft guidance document here….

…including software functions that are part of or control hardware medical devices,” said O’Leary. Stakeholders can submit comments on the draft guidance and download the full draft guidance document here….

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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

…at two years. “These new findings are encouraging news for physicians and the millions of people living with a progressive disease for which there is no cure,” said Philip B….

…at two years. “These new findings are encouraging news for physicians and the millions of people living with a progressive disease for which there is no cure,” said Philip B….

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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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