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Software Medical Device Expertise



  • Emma Law
    27/01/2015 10:04
    I am looking for some advice/consulting from an expert in software medical devices. We are looking to run a clinical trial of a dose prediction software, which is classed as a medical device. If anyone has any expertise in this area and has knowledge of ISO 14971, IEC 62366 and IEC 62304 please contact me.
  • Henny Koch
    10/03/2015 09:28
    Dear Emma, Can imagine your concern. The use of the ISO 62366 on suitability engineering is a usefull tool in this (depending on your concern). This guidance can be combined with a risk based approach following the ISO 14971. Please contact me directly to see where I can be of support. Regards, Henny
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