Market Tracking
Complementary systems all of them aimed at ensuring the monitoring of the product after it is placed on the market, the acquisition of information and the management of data.
For each device, the manufacturer shall design a surveillance system by planning, establishing, documenting, implementing, maintaining and updating a post-market monitoring system for a medical device placed on the market.
It will be proportionate to the characteristics of the product and its risk management.
The data collected by the manufacturer will be used by the manufacturer to maintain and improve the effectiveness of its quality management system, risk analysis and clinical product evaluation, with the appropriate actions associated in the event of detecting incidents or unfavourable trends, by the company’s surveillance system.
For all these reasons, a post-marketing monitoring report will be updated periodically, where the data collected and the consequences derived from them will be collected.
From the information collected, in coordination with the surveillance system, a safety report will be prepared, which will analyse the data collected in relation to the safety and risk analysis of the product.
The surveillance system is a system designed as part of the company’s quality system aimed at implementing a rapid response to possible incidents involving the product and, with it, the company.
Research
Any incident will require at least the investigation of the fact, as well as the communication to the Authorities and other interested parties, as the case may be, as well as the actions defined in each case that attack the problem or its consequences, from the communication of actions or precautions to the withdrawal of the product.
In case of doubts with the monitoring, surveillance or any other related system, do not hesitate to contact us and we will find the solution.
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