During the post-marketing phase of a medical device, Materiovigilance Market is the close monitoring of any undesired performance or characteristic fluctuations by means of a system capable of identifying, collecting, reporting, and reacting to them with field safety remedial actions or device recalls. Medical gadgets and in-vitro diagnostics fall under this category, whereas pharmacovigilance refers to the close monitoring and post-marketing surveillance of pharmaceuticals. Any instrument, apparatus, machine, appliance, implant, reagent, calibrator, software, material, or other similar or related article intended by the manufacturer to be used, alone or in combination, for one or more specific purposes of disease diagnosis, prevention, monitoring, treatment, or alleviation in humans is referred to as a medical device.
Materiovigilance Market is a framework for managing and controlling the appropriate performance of medical devices, as well as the detection and management of communications about changes and incidents that occur after they are marketed. The goal of medical device vigilance is to ensure that patients' and users' health and safety are protected. JSB professionals cooperate with all actors involved in the process for the required fulfillments, managing the following operations on behalf of our clients:
Materiovigilance SOPs are being written and updated.
Manufacturers and authorised representatives receive assistance with the management and notification of incidents that occur in EU and non-EU territory (including the follow-up phase and any Corrective Actions).
Manufacturers and authorised representatives receive assistance with managing post-market and pre-market clinical trials.
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