The logic is sorta backwards. They can’t fix anything because it’s such a pain to get it re-past regulators. Making a large software change would be huge excel

The logic is sorta backwards. They can’t fix anything because it’s such a pain to get it re-past regulators. Making a large software change would be huge excel documents scrutinizing the FMEA and “risk assessments”, and if any risk increases or decreases, goto 510(k)