Technical Manager OF MEDICAL DEVICES

Royal Decree 192/2023 establishes that every medical device manufacturing company will have a university graduate, with appropriate training and experience in relation to the product in their charge, who will exercise direct supervision of the activities carried out by the company for the manufacture of the medical device.

The activities carried out by the company will be understood as the manufacture of the product, together with all the processes related to it, all of them complying with the regulatory requirements applicable to both the company and the product.

The relationship between the company and the technician in charge will be documented by drawing up, and signing, a contract that specifies the time dedication of the person holding the position to the company with which he or she collaborates, as well as the tasks for which he or she is responsible as the technical manager of the company.

As part of the aforementioned tasks or responsibilities, it may be that of acting as a contact person for the surveillance system, by which the product is monitored, after it is placed on the market, in order to collect, analyze and control the data obtained and carry out notification activities to Authorities and Users. in case of incident, or any other that may be required.