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Volume 16 Issue No. 12 |
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By Marie Hattar, Keysight Technologies As the proliferation of wearable healthcare devices expands in terms of application and availability, they’re also becoming smaller and more powerful. In turn, testing and validation in the design phase is becoming increasingly complex. |
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| Featured Articles |
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EPA Issues Final Rule on Ethylene Oxide Emissions By MedTech Intelligence Staff “We’ve arrived at a historically strong rule that will protect the most exposed communities from toxic air pollution while also ensuring that there will be a process that safeguards our nation’s critical supply of sterilized medical equipment.” |
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FDA Outlines its Approach to Artificial Intelligence Regulation By MedTech Intelligence Staff “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together” outlines how FDA’s medical product centers plan to address regulation of AI used in medical products and their development. |
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Medical Device Regulatory Intelligence Summit June 3-5, Washington DC This Summit explores the WHY behind the significant changes across the regulatory landscape and how digital transformation impacts Regulatory Intelligence. Registration is now open for this intimate and interactive forum designed to help regulatory leaders and their organizations recognize and understand key trends, challenges, and solutions impacting MedTech regulatory processes and MedDevice compliance. Hear new ideas, see industry trend data, explore the latest tools, software, and technologies, and network with regulatory officials and industry leaders. |
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Optimizing Vehicle Reimbursements in Field Service By Torben Robertson, Cardata Digital vehicle reimbursement solutions not only ensure fair compensation for employees but also aid companies in managing costs. |
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Make Your Medical Device Pitch For Kids! Announces Grant Winners By MedTech Intelligence Staff The Rubitection skin assessment management tool for chronic wounds and Kofimi Technology’s pediatric pulse oximeter device received a combined $50,000 in grant funding as part of the joint ADPI and MedTech pitch competition. |
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By Joy Greidanus, Celegence 510(k) submissions have been a hot topic of late! Before you start your 510k submission make sure you’re aware of the pitfalls. Being responsible for writing and submitting a 510(k) can seem overwhelming – especially when tied to a scheduled product launch or marketing campaign driven by revenue goals. One of the most influential factors to a successful 510(k) submission is strategic planning. |
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FEATURED LEARNING RESOURCE |
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Discover what to consider when designing and manufacturing point-of-care diagnostic devices, including ensuring measurement accuracy and reliability, user-friendly operation, and scalable production with validated manufacturing processes. |
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| MedTech Library | |
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| Upcoming Events & Webinars |
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April 9, 2024 - 2:00PM - 3:00PM ET |
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June 3-5, 2024 |
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