Human Factors and Usability Regulation in MedTech


MedAcuity Solutions Architect, Bruce Johnston, shares his insights in this month’s issue of Medical Product Outsourcing on how FDA guidance related to human factors and usability can be, as the article name implies, a guide to a more efficient, effective path to success, rather than an obstacle that will hamper development progress.

Discover the significance of human factors and usability regulations in the medical product development process. Rather than seeing these regulations as burdensome, companies should embrace them as valuable tools for improving product safety, user experience, and overall efficiency. By incorporating human factors considerations early in the design phase, manufacturers can ensure compliance with regulatory standards while also enhancing the usability and effectiveness of medical devices. The article advocates for a proactive approach to these regulations, which can lead to better outcomes in both product development and patient care.

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