RenƩe Bailey

Instructional Materials: The Basis for Safety Between Users and Medical Devices

By RenĆ©e Bailey

…costly to implement. Testing alternate versions of instructional designs can also be an effective early testing approach to understand user performance and preferences to down-select options. As the HF testing…

…costly to implement. Testing alternate versions of instructional designs can also be an effective early testing approach to understand user performance and preferences to down-select options. As the HF testing…

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FDA Logo

FDA Updates Breakthrough Devices Program Guidance

By MedTech Intelligence Staff

…effective treatment or diagnosis as compared to the current standard of care. For example, if there is information supporting the device’s use in diverse settings such that a patient population…

…effective treatment or diagnosis as compared to the current standard of care. For example, if there is information supporting the device’s use in diverse settings such that a patient population…

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FDA Logo

FDA Updates Guidance on ISO 10993-1 for Evaluation of Biocompatibility Ā 

By MedTech Intelligence Staff

…recommendations for biocompatibility test article preparation for devices with submicron or nanotechnology components and for devices made from in situ polymerizing and/or absorbable materials, and biocompatibility recommendations when certain materials…

…recommendations for biocompatibility test article preparation for devices with submicron or nanotechnology components and for devices made from in situ polymerizing and/or absorbable materials, and biocompatibility recommendations when certain materials…

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Jennifer Geetter

Successful Development, Approval and Deployment of Digital Health Solutions

By Jennifer Geetter

…results. For example, data strategies that work well for traditional product development and commercialization are not always the right match for digital health. In addition, many companies lack regulatory wisdom…

…results. For example, data strategies that work well for traditional product development and commercialization are not always the right match for digital health. In addition, many companies lack regulatory wisdom…

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David Goldman
Soapbox

Revolutionizing Healthcare: Augmented Reality’s Unprecedented Impact

By David Goldman

…the patient experience and foster better communication between doctors and their patients. Through this technology, medical professionals can present complex information in an accessible and visually compelling manner. Enhanced Symptom…

…the patient experience and foster better communication between doctors and their patients. Through this technology, medical professionals can present complex information in an accessible and visually compelling manner. Enhanced Symptom…

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