[IGSTK-Users] IGSTK and ISO-62304

[Clarkson, Matt]

Hi there,

please forgive me if this covered already…. but after having read:
http://onlinelibrary.wiley.com/doi/10.1002/spe.1075/full

and now reading:
http://ieeexplore.ieee.org/stamp/stamp.jsp?tp=&arnumber=5338024

while IGSTK has been used in research projects and clinical trials and now part of commercial offerings, has it been developed under IEC-62304? If not, then I guess from my perspective it would have to be SOUP? Is that right?

Thanks

Matt

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