Regulatory Information

Quality is our goal in all aspects of the design, production, and distribution of our products.

Each member of GENICON acts as a line of defense to ensure our utmost standard of quality is upheld at all times for all products and operations. We value quality first and diligently perform a multitude of inspections for any item that passes our hands. 

Our trained quality management team diligently oversees every process and maintains regulatory requirements to ensure the product in the hands of our customers is the product that meets our highest standard.

Please review our ISO 13485 registration and Quality Policy below:

GENICON Quality Policy

GENICON shall provide innovative medical devices and services that meet or exceed the expectations of our customers for quality, cost, delivery, and performance, while complying with regulatory requirements and maintaining the effectiveness of the quality management system.


CMC Medical Devices & Drugs S.L.
C/ Horacio Lengo Nº18,
CP29006, Málaga-Spain
TEL: +34951214054