To be able to obtain the prior operating license or the communication of distribution of medical devices, Companies are obliged to have a responsible technician, with a university degree or higher level training cycle that accredits an appropriate qualification depending on the products in their charge, who will exercise direct supervision of the products.
Among the responsibilities of the technician we find:
- Directly supervise the company's activities that fall under medical device regulations.
- Verify that the products comply with the requirements of the regulations that apply to them
- Monitor the documentary archive of products.
- Market surveillance.
- Review and evaluate product-related incidents for the surveillance system and have the means to report them to health authorities.
- Be an interlocutor with the health authorities and collaborate with them in the execution of the appropriate measures, such as the withdrawal of the product from the market.
- Facilitate health authorities, whenever it is required, the documentation that guarantees the conformity of the products with the provisions of the legislation.
- Preparation and supervision of communications for the marketing or commissioning of Class IIa products, IIb.
- Monitoring of messages aimed at advertising and promotion of products.
- Become partner with health authorities and cooperate with them in the implementation of the measures that apply, such as the withdrawal of the product from the market
In this way, BUROTEC Offers regular technical support by one of our experts, with a university degree admitted by the Spanish Agency of Medicines and Health Products to provide this service, or to train the Technician in Charge of your company.
To learn more about our services and how we can help, You can send your inquiry to info@burotec.es or call to the +34 913768950 and request information without commitment, We are at your disposal.
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