Hiiti Sillo, director of the WHO’s office for regulation and safety, told an audience at this year’s IMDRF meeting in Seattle that WHO is putting the finishing touches on a streamlined product ...

The International Medical Device Regulators Forum (IMDRF) has posted a draft guidance for cybersecurity practices for legacy devices, a nod to the number of older devices that are difficult to secure.

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As the world’s medical device regulators work to harmonize how best to regulate software as a medical device (SaMD), MobiHealthNews has learned via a Freedom of Information Act request that the FDA ...