Debiotech Quality Management System has been certified to applicable norms since 1995. Currently, Debiotech is certified to MDD Annex II.3, ISO 9001:2008, and ISO 13485:2003.

Company Quality Policy

The objective of Debiotech’s Quality policy is to favor the development of innovative medical devices that contribute to the improvement of the patient’s Quality of Life, through their ease of use, their functionality, their cost effectiveness, as well as their therapeutic benefits, while consistently fulfilling national and international norms for their safety and performance.

Therefore, Debiotech applies and ensures the effectiveness of a Quality Management System based on the ISO 9001, ISO 13485, and ISO 14971 norms, Annex II of the (European) Medical Devices Directive (MDD), and the Quality System Regulation (21 CFR 820) promulgated by the US FDA.

The Quality Policy has to contribute to the continuous improvement of our company’s performance by recognizing the talent of our employees as well as by caring for our corporate image. It has to represent the systematic determination to make progress and to innovate, making it the driving force behind Debiotech’s activities.

To achieve this goal, the concept of “Quality Intelligence”, which places the Quality Management System and our process for the development of medical devices under one and the same authority, has to facilitate that the Quality Policy is understood, shared, and supported by all.

Periodic management reviews ensure updates of the Quality Policy, its translation into operational quality objectives, and the availability of the necessary resources.