Quality System

MEDI-LINE has built a reliable quality system to meet the requirements of the strict regulatory environment and the most demanding customers.

This quality system is certified EN ISO 9001: 2008 and EN ISO 13485: 2003 to support the requirements of the Medical Devices directives and GMP's.

Audits from customers such as Johnson & Johnson or GE Healthcare are regularly and satisfactorily performed. Being approved or certified supplier for these major players is our pride.

MEDI-LINE is willing to listen specific customer needs to support the continuous improvement process of its quality system.

Our manufacturing conditions include:

• Assembly Clean Rooms ISO 7 (class C)
• Extrusion/Injection Molding Clean Room ISO 8 (class D)
• Laminar flows.

To download our certificate – click here.