24.05.2019 | Novo Klinik-Service GmbH has been successfully certified according to the updated version of EN ISO 13485. EN ISO 13485:2016 is a further development of the previous version almost unchanged since 2003. A large number of minor changes have resulted in greater proximity to the American set of rules 21 CFR part 820 (Quality System Regulations) and now also in establishing the requirements of the Notified Bodies from NBOG and MEDDEV papers in the standard.
Additional requirements in process risk management, process validation and compliance build the core of the revised version. The updated standard covers the complete life cycle of medical devices. It checks whether a quality management system is capable of continuously managing and guiding the life cycle of medical devices and their associated activities. This is to ensure the fulfillment of the product requirements through the effectiveness of the introduced processes. It thus makes a significant contribution to the safety of patients and users.
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 particular responsibility as a manufacturer of medical devices. Therefore, our quality management was successfully audited during business operations in accordance with the international standard EN ISO 13485:2016. Herewith, we make sure to meet all current requirements for the purpose of maximum patient safety and customer satisfaction.
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.
You can download our certificate here.