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Leveraging AI and ML in Medical Products – Part 2
Bob Bouthillier Director, Electrical Engineering, Veranex
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Achieving Regulatory Clearance for a Novel Device – Provisio Medical
Provisio™ SLT IVUS™ System Creating a novel medical device typically includes innovation around treatment, capabilities, cost reduction, or usability...
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Leveraging AI and ML in Medical Products – Part 1
Bob Bouthillier Director, Electrical Engineering, Veranex In this three-part series, Bob Bouthillier discusses the state of artificial intelligence...
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Building Blocks of Quality: The Role of Design Control in Medical Device Development
Design Control is a critical quality management system process that allows for a concept be developed and evolve into a reliable and safe product...
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Playing Defense: Cybersecurity for Diagnostic Devices
No industry or device is immune from the risk of cyber attacks. And it’s especially important that medical devices including diagnostic instruments...
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Expert Insights: Project Management with Matt Perry
Recently we sat down with Matt Perry, VP of program management at Veranex, to talk about common project management issues within medtech, and his...
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Ensuring Compliance with New FDA Guidance on Software Documentation & Cybersecurity
New guidance from the FDA replaces similar, but now obsolete, guidance. Some of the guidance was issued in response to the PATCH Act, which is a 2022...
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Clinical Utility Evidence Planning: Framework, Assessment Techniques, and Case Study for a Diagnostic Test
Clinical utility describes the usefulness of a medical product (device, diagnostic/prognostic, or therapeutic) for physicians and/or patients, and...
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Appropriate, early planning for medical device development could help outshine the darkness of Alzheimer’s disease
Exciting developments in the area of medical devices for the diagnosis, prognosis, treatment/management, and monitoring of Alzheimer’s disease (AD)...
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Document Review: A Nuanced Process in Medical Writing
Veranex is determined to provide complete support to our healthcare partners to reach our shared goal of advancing medical care and improving...