• Sven Jungmann

SaMD Manufacturer

The SaMD manufacturer is the person or entity (company or corporation) legally responsible for the design and/or manufacturing of a SaMD. The manufacturer must ensure regulatory compliance, achieving both pre- and post-market requirements.

One quick point to note: If a device is adapted for an individual patient, but used for its intended purpose, this “adapter” is not considered the “manufacturer.” However, if a device is modified or repurposed for a different use (independent of the original manufacturer), the “modifier” is a “new manufacturer” and legally responsible for the modified device.

Source: http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-131209-samd-key-definitions-140901.pdf

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