GENERAL APPROACH IN DEVELOPING TECHNICAL DOCUMENTATION OF A MEDICAL DEVICE
Science. Business. Society., Vol. 2 (2017), Issue 1, pg(s) 35-37
In the following report are shown the main criteria for development of a Technical documentation for a medical device according to Council Directive 93/42/EEC. A general approach is presented as a result of a systematisation of the requirements of the European technical legislation. This approach can be used as a base for developing the technical documentation of all classes of medical devices.