Software Medical Device Expertise
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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.
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.