Francesca Gazzotti | Quality System and Certification Manager

As Quality System and Certification Manager I am in charge of managing and regulating the processes that the company puts in place in order to produce and market its products, both in Europe and outside.

C-Tech, as a manufacturer of medical devices, must in fact follow a certification path both for its quality system ¬– according to the ISO 13485 standard – and for its product, according to the applicable European standards.

My team and I have the task of maintaining a certified and updated quality system that allows to establish and maintain the effectiveness of processes, ensuring consistency between design, development, production, installation and supply so that medical devices are safe when used for the purpose for which they were created.

At the same time, the CE marking on the medical device is of fundamental importance for the Quality System, obtained by undertaking a certification process and demonstrating to a notified body that it can guarantee compliance with the requirements of the applicable legal standards.

In my department it is also necessary to provide for the constant updating of documentation and certifications, to be able to face regulatory changes and keep up with the requests of notified bodies. The body that certifies C-Tech Implant’s higher risk class system and products is the German notified body Tüv Süd, recognized as one of the most important and prestigious in the world, which carries out annual checks necessary to supervise the manufacturer during the period of validity of their certifications.

Finally, we try to focus a lot on the continuous training of all company figures in order to improve the 360-degree monitoring skills of the processes, so that the company can achieve constant progress and continue to provide high quality standards on the national and international markets.