Quality

We take our responsibility seriously, for developing, manufacturing and marketing our instruments for the benefit of patients. In doing so, we strive to aWe assume responsibility for the development, manufacture, and placing on the market of our medical devices. This responsibility is underpinned by the consistent compliance with regulatory requirements as well as a quality-, safety-, and risk-based approach throughout the entire product life cycle. Our focus is on the continuous, systematic, and measurable improvement of product quality, process reliability, and the performance of our services, based on a risk-based quality management approach.sustain and measurably improve the quality and performance of our products, services, and processes.

Quality Standards

Our quality management system is process-oriented and ensures compliance with all applicable national, European, and international legal, regulatory, and normative requirements for the development, manufacture, and placing on the market of our medical devices.
The effectiveness of the established processes is continuously monitored, evaluated, and documented by the Quality Management department. Standardized procedures and clearly defined responsibilities ensure consistent implementation of quality requirements across all business areas and production sites.
In addition, our suppliers and external service providers are subject to structured monitoring to ensure that supplied materials, components, and services consistently meet the defined requirements and specifications.

Certificates, Product Registrations and Import Licenses

Our quality management system is certified according to ISO 13485:2021 and meets the requirements of the European Medical Device Regulation (MDR).
Our medical devices bear the CE marking and, depending on the respective product and its regulatory status, are certified either in accordance with the Medical Device Directive (MDD) or already in accordance with the Medical Device Regulation (MDR). Products that are currently still certified under the MDD will be transitioned to the MDR certification process within the applicable transition periods.
For the respective target markets, we comply with the applicable regulatory requirements for medical devices, including the necessary product registrations and import licenses.