A pity. For me the IEC 62304 is one of the standards who make the most sense. For me traceability has one more very nice aspect: you always trace whatever you

A pity. For me the IEC 62304 is one of the standards who make the most sense. For me traceability has one more very nice aspect: you always trace whatever you do (think merge request or it deployment request / changes) back to the reason/authorization why you do it (think project, change request, defect, ...). Like that you are never in the limbo why you do something. Especially in regularity domains that is a must have but honestly i would not run a company otherwise. Because it also ensures that money is spent where you want it. With or without requirements in between them.