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Medical device manufacturers developing for both the US and European markets often treat FDA and MDR usability requirements as two separate compliance tracks — one human factors program for the FDA submission, another usability engineering effort for the Technical Documentation under MDR. This separation is rarely necessary, and it's expensive. Read carefully, the two frameworks converge far more than they diverge. The organizations that recognize this early build one usabili

Summative usability evaluations tend to get the spotlight. They sit at the end of the design cycle, they carry regulatory weight, and their outcome — pass or fail — feels decisive. But the quality of a summative study is rarely determined by the study itself. It's determined by everything that happened before it: the formative work that shaped the interface, surfaced its failure modes, and taught the design team where real users actually struggle. Treating formative testing a