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USFDA Med Dev Guidance: Applying Human Factors and Usability Engineering
As medical devices become increasingly sophisticated, ensuring that they are safe and intuitive to use is just as important as demonstrating their technical performance. Many device-related incidents are not caused by product failure but by use errors that arise from complex interfaces, confusing instructions, or challenging use environments. The U.S. Food and Drug Administration (FDA) has updated the guidance Applying Human Factors and Usability Engineering to Medical Device
Sharan Murugan
Aug 53 min read
UK MHRA Med Dev Guidance: Applying Human Factors to Medical Devices
The Medicines and Healthcare Products Regulatory Agency (MHRA) published its comprehensive guidance titled “ Applying Human Factors and...
Sharan Murugan
Jan 16, 20252 min read
USFDA ME Guidance: Voluntary Malfunction Summary Reporting (VMSR) Program
Recently on 12-December-2022 USFDA's Center for Biologics Evaluation and Research and Center for Devices and Radiological Health released...
Sharan Murugan
Dec 14, 20221 min read