Medical Devices
According to the German Medical Devices Act (MPG) §19 para. 1 and Annex X para. 1 of the EU Directive 93/42 /EWG, the suitability for the intended use must be demonstrated for each medical device and its medical risks need to be assessed. This is done with a clinical evaluation, based on medical literature, own investigations and / or on the basis of clinical trials.
Dr. Notghi Contract Research GmbH has experienced and dependable experts in this field.
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