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

Input and support from experts within your target disease area are vital to the development and commercialization of new medical technologies. But it can be difficult, especially for new companies,…

Input and support from experts within your target disease area are vital to the development and commercialization of new medical technologies. But it can be difficult, especially for new companies,…

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Adrian Jennings

Using RTLS To Improve Operational Efficiency

By Adrian Jennings

…an epidemic of disease, but of missing mobile medical equipment (MME). The side effects include operational inefficiencies resulting in increased costs, wasted time, and—perhaps most alarmingly—patient care being compromised. However,…

…an epidemic of disease, but of missing mobile medical equipment (MME). The side effects include operational inefficiencies resulting in increased costs, wasted time, and—perhaps most alarmingly—patient care being compromised. However,…

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FDA Logo

FDA Announces Additional Steps to Modernize Clinical Trials

By MedTech Intelligence Staff

…will be open for public comment for 60 days. The ICH Expert Working Group will review and consider comments on this draft guidance, as well as feedback from other ICH…

…will be open for public comment for 60 days. The ICH Expert Working Group will review and consider comments on this draft guidance, as well as feedback from other ICH…

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Artificial Intelligence Graphic

AAMI and BSI Partner to Publish Guidance on Artificial Intelligence

By MedTech Intelligence Staff

…management and corresponding general aspects for products with a health purpose including medical devices, and IEC (International Electrotechnical Commission) Subcommittee (SC) 62A/Common aspects of medical equipment, software, and systems.  …

…management and corresponding general aspects for products with a health purpose including medical devices, and IEC (International Electrotechnical Commission) Subcommittee (SC) 62A/Common aspects of medical equipment, software, and systems.  …

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Monali Bhansali
Soapbox

Beyond EU MDR: Unleashing Opportunities to Innovate and Ensure Patient Safety

By Monali Bhansali

…include: Growing Complexity of Medical Devices: One of the biggest challenges in meeting regulatory requirements is the growing complexity of medical devices. This increasing complexity makes it difficult for manufacturers…

…include: Growing Complexity of Medical Devices: One of the biggest challenges in meeting regulatory requirements is the growing complexity of medical devices. This increasing complexity makes it difficult for manufacturers…

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Mother Earth graphic

Developing Sustainable Medical Devices

…is often where the work starts,” said Unger. “Set a target, communicate it companywide, and hold yourself accountable. One option is to create incentives.” Procurement Companies can commit to green…

…is often where the work starts,” said Unger. “Set a target, communicate it companywide, and hold yourself accountable. One option is to create incentives.” Procurement Companies can commit to green…

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Bret Ludwig, 3M
MEDdesign

Wearable Design Challenge: Stick-to-Skin Adhesion

By Bret Ludwig, Ph.D.

…years ago. With these advances, one commonly overlooked layer in the early stages of device development is the stick-to-skin adhesive. The Challenge of Sticking to Skin Ask a pressure sensitive…

…years ago. With these advances, one commonly overlooked layer in the early stages of device development is the stick-to-skin adhesive. The Challenge of Sticking to Skin Ask a pressure sensitive…

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