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The International Medical Device Regulators Forum (IMDRF) has posted a draft guidance for cybersecurity practices for legacy devices, a nod to the number of older devices that are difficult to secure.

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Navigating the SaMD regulatory pathways is one of the most complex yet important aspects of product development for medical technology startups. Startups in this field are required to meet local ...

The IMDRF Coding solution integrates seamlessly into AssurX EQMS, ensuring compliance with EU MDR and FDA guidelines while reducing costs by up to 72%. Having an eQMS software partner that can help us ...