Each manufacturer of Medical Devices has to make sure that his product causes no unjustifiable risks. This must be assessed and presented on the basis of a systematic and reproducible procedure.
The standard DIN EN ISO 14971 describes a method to trace this approach systematically and to maintain it throughout the whole life cycle of a product, from the first idea of the development department until the product is phased out.
Within the framework of this course you learn this systematics and the step-by-step proceeding until the complete “risk management file” is finally available.
You will also recognize in which way a reasonable risk management will help you saving expenses and avoiding complaints (and thereby in the end unsatisfied customers).
This course includes also workshops in which the theoretical knowledge will be transposed to the practice.