Sebia operates in a highly regulated worldwide environment, with a set of requirements that are increasingly demanding. While meeting those, Sebia does rely on Management Systems designed to improve our customers’ satisfaction, to meet regulatory requirements all over the World and to lead to business efficacy.

Quality and Compliance are deeply integrated into the Company’s culture and operations.

Sebia is structured around fundamental and closely interconnected processes. Among them: Management Control, Environmental Program, total Product Life Cycle, Customer Focus (Needs, Care and Distribution Network), Regulatory Watch and Product Submissions, Post Market Surveillance and Vigilance, and Resources Management.

The main components of our Quality Management System are:

  • Total customer satisfaction
  • Implementation by all employees
  • Process and risk-based activities
  • Fully integrated system
  • Business-driven approach
  • Continuous improvement
  • Efficient information and communication


Sebia implements a stringent policy of control and traceability throughout the production and distribution chains. This provides our customers a high and constant quality of products and services, as well as the capacity for Sebia to communicate quickly and efficiently any relevant product information.

During the Design Control process, the devices are verified &/or validated according to all applicable standards.

All Sebia In Vitro Diagnostic devices are CE marked and registered in many countries around the World depending upon our business geographic footprint.

Sebia’s Quality Management System is ISO 13485:2016 certified and complies with the requirements of the MDSAP.