RenƩe Bailey

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

By RenĆ©e Bailey

…not available to end users. In this article, we will explore the importance of combining instructional design principles with human factors engineering (HFE) to design instructional materials for medical devices….

…not available to end users. In this article, we will explore the importance of combining instructional design principles with human factors engineering (HFE) to design instructional materials for medical devices….

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FDA Updates Breakthrough Devices Program Guidance

By MedTech Intelligence Staff

…potential for the device to make a clinically meaningful impact and the risks and benefits compared to standard of care. The final guidance also explains that the FDA may consider…

…potential for the device to make a clinically meaningful impact and the risks and benefits compared to standard of care. The final guidance also explains that the FDA may consider…

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

By MedTech Intelligence Staff

…material supplier, a master file for the material component(s) may assist in determining the formulation of some components of the final device.” ISO 10993-1 dictates that any in vitro or…

…material supplier, a master file for the material component(s) may assist in determining the formulation of some components of the final device.” ISO 10993-1 dictates that any in vitro or…

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Jennifer Geetter

Successful Development, Approval and Deployment of Digital Health Solutions

By Jennifer Geetter

company is ahead of the curve. Such enthusiasm can outpace the speed with which life sciences companies can develop dedicated digital health strategies, either as companions to existing products or…

company is ahead of the curve. Such enthusiasm can outpace the speed with which life sciences companies can develop dedicated digital health strategies, either as companions to existing products or…

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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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FDA Issues Three New Draft Guidances on the 510(k) Program

By MedTech Intelligence Staff

…in learning more about these draft guidances and the FDA’s ongoing efforts to modernize the 510(k) Program. Stakeholders are also encouraged to submit comments to the FDA on the draft…

…in learning more about these draft guidances and the FDA’s ongoing efforts to modernize the 510(k) Program. Stakeholders are also encouraged to submit comments to the FDA on the draft…

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