13.03.2018 – Novo Klinik-Service GmbH has been successfully certified according to EN ISO 13485. As a manufacturer of medical products, we strive to ensure the best possible safety and quality of our products.
For us, quality means optimal patient care. It is important to us that all our processes from the development to production and distribution of our medical products comply with the requirements of the German and European medical device regulations and their directives. We are aware of the special responsibility that we bear as a manufacturer of medical devices.
Therefore, our quality management was successfully audited in accordance with the international standard EN ISO 13485 during business operations. This certification makes high demands on the compliance of all process steps. Thus, the consistent and complete documentation and risk management must be transposed at all times. It is not just a matter of minimizing the risk but to guarantee the optimal traceability of products in case of any problems.
We develop our products in a trustful and longstanding collaboration with doctors and nursing staff. Our trained medical device consultants participate in continuing education and advise our customers on product selection. By comprehensive product and user trainings at the customer’s site, we ensure optimal handling of our products.
For our products, we use high-quality materials from partner companies within the EU. We mainly produce at our company headquarters in Bergheim near Cologne and rely on the very latest technology.
By issuing the certificate, the Notified Body ecm declares that our company applies a quality management system for the design/development, production and distribution of medical consumables, accessories and application aids for clinic and care.
Please find our certificate here.