Does anyone have a Word table or Excel file that provides the documentation required for an FDA pre-market submission (510(k) or PMA), including a comprehensive potential list of deliverables. I know that this exists in the FDA Guidance, but it does not include a list of deliverables.
I don't know if this has evolved in the last year or two with the 2015 amendment to IEC 62304, and considering the Guidance is from 2005.
Also, do you know if there is a Standard or Guidance that relates to medical device software that will connect to the "cloud". The closest I could come was IEC/TR 80001-1 Application of risk management for IT Networks incorporating medical devices, but I don't think that would be correct.
Thanks.
I don't know if this has evolved in the last year or two with the 2015 amendment to IEC 62304, and considering the Guidance is from 2005.
Also, do you know if there is a Standard or Guidance that relates to medical device software that will connect to the "cloud". The closest I could come was IEC/TR 80001-1 Application of risk management for IT Networks incorporating medical devices, but I don't think that would be correct.
Thanks.