Cabonce and Ehman WuXi

The MDR Deadline Extension: Use the Time Wisely

By Kim Ehman, Ph.D., Mark Cabonce

…estimated that, at the current pace, as many as 7,000 devices could be certified by the original MDR compliance deadline, which clearly would not have eliminated the backlog. According to…

…estimated that, at the current pace, as many as 7,000 devices could be certified by the original MDR compliance deadline, which clearly would not have eliminated the backlog. According to…

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BSC Logo

Boston Scientific Elects Dr. Jessica L. Mega and Susan E. Morano to Board of Directors

By MedTech Intelligence Staff

…a subsidiary of Alphabet Inc. focused on life sciences and health care. She was company’s chief medical and scientific officer from 2015 to January 2023. Prior to joining Verily, Dr….

…a subsidiary of Alphabet Inc. focused on life sciences and health care. She was company’s chief medical and scientific officer from 2015 to January 2023. Prior to joining Verily, Dr….

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Gabe Siftar and Matt Nowell

Managing Software Vulnerabilities: How to Utilize ISA/IEC 62443 and Software Bills of Materials

By Gabe Siftar, Matt Nowell

…are machine-readable inventories of software components akin to an ingredients list. Medical devices qualifying as cyber devices contain software that is typically built using components from third parties—referred to in…

…are machine-readable inventories of software components akin to an ingredients list. Medical devices qualifying as cyber devices contain software that is typically built using components from third parties—referred to in…

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Chris Fourment

Decoding FDA Guidance on Decentralized Trials

By MedTech Intelligence Staff

…HCPs to take part in DCTs? Fourment: One potential challenge is compensation. You are taking up the physician’s time, so how do you compensate them effectively? The FDA offers some…

…HCPs to take part in DCTs? Fourment: One potential challenge is compensation. You are taking up the physician’s time, so how do you compensate them effectively? The FDA offers some…

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Vik Anantha

Data-driven Surgery: The Next Step in Improving Care and Operational Efficiency

By Vik Anantha

…[9] Nèwel Salet, Vincent A. Stangenberger, Rolf H. Bremmer, Frank Eijkenaar. Between-Hospital and Between-Physician Variation in Outcomes and Costs in High- and Low-Complex Surgery: A Nationwide Multilevel Analysis. Value in…

…[9] Nèwel Salet, Vincent A. Stangenberger, Rolf H. Bremmer, Frank Eijkenaar. Between-Hospital and Between-Physician Variation in Outcomes and Costs in High- and Low-Complex Surgery: A Nationwide Multilevel Analysis. Value in…

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Sanobar Syed

Market Forecasting: Solving the Problems of Too Little or Too Much Data

By Sanobar Syed

…as many lack reliable data intelligence. Often companies are faced with limited data or, thanks to the explosion of AI and other data collection technologies, vast amounts of data that…

…as many lack reliable data intelligence. Often companies are faced with limited data or, thanks to the explosion of AI and other data collection technologies, vast amounts of data that…

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Steve Thompson

Risk-Based CSA Validation: Ensuring the Least Burdensome Approach

By Steve Thompson

…Doing It. By Lisa Weeks. https://www.valgenesis.com/blog/worried-about-computer-software-assurance-relax-youre-probably-already-doing-it [3] How Computer Software Assurance Will Impact Traditional CSV Testing. By Steve Thompson. https://www.valgenesis.com/blog/how-computer-software-assurance-csa-will-impact-traditional-software-testing [4] Testing and validation: From hardware focus to full virtualization?…

…Doing It. By Lisa Weeks. https://www.valgenesis.com/blog/worried-about-computer-software-assurance-relax-youre-probably-already-doing-it [3] How Computer Software Assurance Will Impact Traditional CSV Testing. By Steve Thompson. https://www.valgenesis.com/blog/how-computer-software-assurance-csa-will-impact-traditional-software-testing [4] Testing and validation: From hardware focus to full virtualization?…

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Juliane Ray

Facilitating Connections with MedTech KOLs

By MedTech Intelligence Staff

…during development or commercialization that you hope to address with Link? Ray: Before coming to Veeva, I was the head of commercial operations at a cardiovascular company, so I had…

…during development or commercialization that you hope to address with Link? Ray: Before coming to Veeva, I was the head of commercial operations at a cardiovascular company, so I had…

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