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The principal purpose of materiovigilance is to improve the protection of the health and safety of patients, users and others by reducing the likelihood that incidents related to the use of a medical device will reoccur.
Medical Devices Directives ensure that adverse incidents are evaluated and, where appropriate, information is disseminated in the form of a National Competent Authority Report (NCAR) with the objective of preventing the repetition of such incidents through the adoption of appropriate corrective actions to be taken in the field.
Medwork can provide you with a vigilance reporting system that is compliant with MEDDEV 2.12-1 r 6, and develop all the standard operating procedures required.
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