Quality Management and Certification
Testing is a major part of the responsibility our customers have for their patients. To ensure precise and fully reliable test results, diagnosis and research operations need to be of the highest quality. It is this quality that RR Mechatronics instruments deliver every day.
To maintain this level of quality, we rely upon our comprehensive Quality Management System controlled by our Quality Assurance & Regulatory Affairs department. This system involves every single measure we take to meet our clients’ expectations and needs. From R&D to production, from timely delivery to planned or emergency maintenance: Quality Management is not an isolated process, but involves every aspect of our organization. Moreover, it fuels our pursuit of improvement.
Quality Management System certification
RR Mechatronics’ ISO certification – EN ISO 13485: 2016 – assures our customers of the quality of our products and services.
EN ISO 13485 specifies requirements for a quality management system that enables the company to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and the specific regulatory requirements applicable to medical devices and related services.
RR Mechatronics’ Quality Management System is compliant with the United States FDA Quality Systems Regulation for medical devices.