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’ two ISO certifications – EN ISO 13485: 2012 and ISO 9001: 2008 – assure our customers of the quality of our products and services.

ISO 9001 refers to the company’s ability to provide products that meet customer and applicable regulatory requirements and aims to enhance customer satisfaction through the effective application of the system, including processes for continuous improvement of the system and the assurance of conformity to customer and applicable regulatory requirements.

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 also certified compliant with the Canadian Medical Device Regulations according Canadian standard CAN/CSA ISO 13485.

RR Mechatronics’ Quality Management System is compliant with the United States FDA Quality Systems Regulation for medical devices.

dekraseal ISO Certificates