The companies that develop activities related to medical device, they are subject to Regulation by the Spanish medicines and medical devices Agency (AEMPS) by means of the corresponding Manufacturing license, Import and distribution.
The regulation of the activity of distribution will be competition of the respective Ministries of health of the communities autonomous. In addition to license prior, the companies must have compulsorily with a Technical Manager that should have a profile academic clearly defined and count with the approval of the AEMPS.
Burotec Consulting Department we put at your disposal our team of experienced professionals in health sector, that you will guide you step by step to get your licenses, managing all the necessary formalities to the relevant official bodies.
THAT YOU OFFERED BY BUROTEC: TECHNICAL GUARANTOR
BUROTEC offers periodic technical assistance by one of our experts, with degree College admitted by the direction General of Pharmacy and products health of the Ministry of health to provide the service of Technical Manager for the marketing of health product and cosmetic, either, to train the technical manager of your company.
The responsibilities than assumed by law technical manager are as follows:
- Supervise the activities of manufacture and/or import.
- Check that the products meet the requirements of the current regulations.
- Preparation and supervision of the technical documentation required by the regulations in force.
- Monitor the documentary archive of products.
- Review and evaluate the product-related incidents and claims.
- Qualification final and release (If applicable) of the batch of products manufactured / imported.
- Facilitate health authorities, whenever it is required, documentation indicating the suitability of products with the provisions of the legislation.
- Become partner with health authorities and cooperate with them in the implementation of the measures that apply.
- Communicate to the health authorities any change or modification that occurs in the installation carrying out activities of manufacturing or storage.
- Monitoring direct from the activities of distribution.
- Supervision of the advertising and promotion of the products.
BUROTEC offers you in-company training, specifically designed for your company, with the objective of training its technical manager delving into each of the responsibilities established by the Spanish authorities as in the Good manufacturing practices to ensure the placing on the market of the cosmetic product with full guarantees of quality and safety for the end user
To learn more about our services and how we can help, You can send your inquiry to firstname.lastname@example.org or call to the +34 913768950 and request information without commitment, We are at your disposal.