One of the difficult challenges with product development for medical device and HealthIT manufacturers is to properly delineate the design requirements – what is product level versus what is design level. There are many reasons to get this right because if one doesn’t the impact could cause significant delays in development at least and inadequate testing or even recalls at worst.
Often what is clearly a very detailed software requirement is treated like 21CFR820.30(c) Design Input – which leads to the likelihood that many unnecessary activities may be triggered when that software requirement changes. Furthermore, very often the product level requirements are absent or poorly written to capture the “real” design input – the intended use and medical claims of the device.
IEC 62304 and IEC 82304 can be helpful in sorting this out. Additionally, we created this job aid which compares the IEC 62304 and IEC 82304 elements for requirements. Keep in mind this is only intended to be used as a starting point and requires interpretation based on knowledge of each standard and the type of device or Health IT involved, and as always, the intended use and overall safety risk of the product.
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