Quality & Regulatory
Belimed’s solutions comply with the highest quality standards, and we are committed to applying these without compromise, every day. We are always looking for innovative solutions to improve reliability, efficiency and sustainability in CSSD. At the same time, we strive to achieve ideal conditions for a better working environment.
We define our quality principles as follows:
- Understanding and meeting customer requirements
- Safe products and services
- Error-free and on-schedule deliveries – first time right
- Cost reduction through error avoidance
- Safe and healthy working environment and satisfied employees
- Compliance with applicable directives, laws and standards
To meet these principles, we adhere to a quality policy that is regularly reviewed to seek opportunities to improve processes, products and services. Belimed employees are qualified individuals committed to supporting our quality policy. Employees are trained to follow process and product specifications, to identify safety risks and quality improvement potential, and to initiate and implement actions for improvement. Management exemplifies a commitment to our quality policy through daily activities.
In order to meet the highest quality standards, Belimed maintains a quality management system that complies with ISO 13485, MDD93/42/EEC and 21 CFR 820, and is valid for all European locations as well as the US site. The European locations are ISO 13485 certified. Belimed is working to implement the new medical device regulation MDR 2017/745/EU on schedule. In addition to regular monitoring audits by the notified body, Belimed maintains an internal audit system to ensure that it complies with and continually improves on the quality management system’s requirements for its products. The audits and inspections monitor all regulatory requirements and safety aspects of the Belimed products and the quality management system.
Belimed is FDA Inspected
Belimed is a manufacturer of medical devices and machinery. Belimed has a quality management system based on ISO 13485, MDD93/42/EEC and 21 CFR 820. Belimed has been inspected by the FDA several times, the latest inspection was in 2019.