In my past company we looked at EU MDR class 2a certification, we established it would cost around 100k€/a to get and maintain all necessary certifications. Essentially hiring a full-time resource to do all documentation, plus costs due to slower work cycles, plus certification reviews, plus external consulting as needed.
Ultimately we closed shop before we starting going down that route, so I cannot tell if that number was correct.
Ultimately we closed shop before we starting going down that route, so I cannot tell if that number was correct.