After obtaining the CE certification, which proves that the developed medical device fulfills the minimum legal and technical requirements in safety matters in the Member States of the European Union, the innovative and pioneering technique for the Pectus Excavatum treatment continues to obtain quality certifications.
The Spanish Agency of Medicines and Medical Devices (AEMPS) and the French National Agency for Medicines and Health Products Safety (ANSM) have granted Ventura Medical Technologies the authorisation to market Pectus Up Surgery Kit throughout Spain and also in France.
The AEMPS is responsible for giving the authorisation to commercialize industrially fabricated drugs for human use, and for inspection and adaptation of the ones already on the market. Accordingly, it is the maximum responsible for controlling drugs and medical devices of state competency, as well as preserving the quality guarantee, safety, effectiveness, information and accessibility to drugs and medical devices in Spain.
The state organism has certified that the Pectus Up Surgery Kit is a quality medical device, and that it perfectly complies with the Spanish regulation regarding medical devices. Therefore, the AEMPS authorises Ventura Medical Technologies to distribute the most innovative product for the treatment of Pectus Excavatum.
However, the Spanish state is not the only European country which recognises Pectus Up Surgery Kit benefits. The ANSM has opened the borders to a product and a technique so far non-existent, guarantors of less pain, absence of important complications and a faster recovery.
The ASNM is a French public organization with the purpose of assessing the sanitary risks that drugs and other medical devices may present for the French population. Its certification guarantees the quality of Pectus Up Surgery Kit in accordance with the French standards in matters of quality, safety and efficacy.