Debiotech is an ISO 9001 / EN 46001 certified company since 1995. Since July 2001 Debiotech is certified ISO 9001:2000 and EN ISO 13485:2000

Company Quality Policy

Debiotech applies and ensures the continuous improvement of a Quality System based on the ISO 9001 and ISO 13485 norms, Annex II of the European Medical Devices Directive (MDD, 93/42/CEE) and the Quality Systems Regulation of the American Food and Drug Administration (FDA)..

The Quality System shall stimulate the development of innovative medical devices that seduce the user of tomorrow by their ease of use, functionality, cost, and that meet international safety and performance standards.

The Quality System shall facilitate the industrialization and manufacture of these devices by subcontractors selected and controlled by Debiotech.

The Quality System shall favor the continuous improvement of corporate performance by targeting notably: patient safety and comfort, the appreciation of its employees’ talents, corporate image, productivity increase and market expansion.

The Quality System shall contribute to improving the safety around the devices developed by Debiotech.

The quality of its products concerns General Management and all employees.

General Management commits itself to make the necessary resources available to apply the corporate quality policy and make it succeed.