Even as a class I device (which an ekg is emphatically never going to be), the ISO audit is three months between the first two stages alone. Under MDD 3 months

Even as a class I device (which an ekg is emphatically never going to be), the ISO audit is three months between the first two stages alone. Under MDD 3 months is a push, but under MDR I think 6 is a much more realistic minimum (if you're starting from literal zero).