IMDRF (International Medical Devices Regulators Forum)guidance on standalone software

[Pads38]

The IMDRF (the organization that replaces GHTF) have released a draft document on Standalone Medical Device Software, with key definitions.

It is likely this will be the starting point for how this type of software is regulated in the future. Comments are invited, with a deadline of August 30 2013.

Document is here:
https://imdrf.org/docs/imdrf/final/consultations/imdrf-cons-sskd-130701.pdf

 

[Stijloor]

Re: IMDRF (International Medical Devices Regulators Forum)guidance on standalone soft

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