ESR14: Towards standardized EMC assurance case patterns for the certification of medical equipment KU Leuven
In the end, both the EMC and Medical Directives require the manufacturer to clearly document all steps taken and decisions made to guarantee and check the conformity of the product in the so-called Technical Documentation. The purpose of the Technical Documentation is to make it possible for an external independent, external assessor or for the final user to (i) reproduce the whole reasoning followed by the manufacturer, (ii) assess the ...