Medical Device and Diagnostic Industry (MD+DI)

Why FDA's Latest Guidance Makes Human Factors a Make-or-Break Issue for Device Approval

The FDA released updated guidance on May 29, 2026, formalizing expectations for human factors information in medical device ...
RAPS

Human Factors Studies for Generic Combo Products: FDA Offers Draft Guidance

The US Food and Drug Administration (FDA) on Friday continued its flurry of draft guidance for generic drug companies (releasing its third in the last two days), this one for potential applicants ...
RAPS

FDA finalizes guidance on use of human factors studies in combination product development

The US Food and Drug Administration (FDA) finalized its guidance for industry on the use of human factors engineering (HFE) studies to support the development of combination products. The final ...
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Guidance for safer AI-enabled medical devices: Researchers highlight the importance of human factors

AI-enabled medical devices promise improved medical care and support for health care professionals. However, the safety and performance of such systems not only depends on algorithms or technical ...
JD Supra

Beyond Safety & Effectiveness: Business Reasons to Prioritize Human Factors in Medical Device Design

The preceding discussion implies that human factors research and user-centered design are critical for optimizing user-device interactions, and also that testing should be done early and often.
Business Wire

Rimkus Acquires Human Factors Consulting Services, Incorporated, Enhancing Expertise in Human Factors and Medical Device Consulting

HOUSTON--(BUSINESS WIRE)--Rimkus Consulting Group, Inc. (“Rimkus”), a premier global provider of engineering, technical consulting, and life sciences services, is pleased to announce the acquisition ...
JD Supra

Bridging UX and Product Safety Through Human Factors

Insurance, finance, and legal professionals—particularly, attorneys/legal counsel representing companies with products in development or in ...