Quality

Quality Management System and Compliance
Quality is not a marketing term but a precondition to produce medical products and an obligation to you as our customers and patients.

Therefore, we are certified by DIN EN ISO 13485 and we make sure our partners are equally certified.

Interdisciplinary Development and Assessment of Products by Experts

During the development and evaluation of products, a thorough examination and evaluation is carried out by experts (renowned surgeons, engineers, nurses and medical technology experts) with regard to functionality, user-friendliness, quality and safety. These product assessments are interdisciplinary and meet the highest standards due to their integrated approach.
 

Quality Assessments

When selecting suppliers, potential suppliers as well as their quality management systems are examined by a qualified auditor carrying out pre-assessments. Before a supply contract is concluded, a quality assessment is performed on site in order to thoroughly assess product quality, process quality and the quality management system itself.
 

Technical Quality Assurance

To agree specifications (design, raw material, processing, etc.) and production standards, contracts such as the Technical Quality Assurance are signed with the supplier. The Technical Quality Assurance defines, inter alia, the way in which quality controls are carried out and compliance with regulations (batch tracking, storage of production data, etc.) in general.
 

Continuous Observation and Vigilance

All suppliers are systematically monitored by Nexon Medical as part of the supplier audits. Besides the permanent post market surveillance and vigilance, the monitoring of the CE certificates and the CE certification processes are executed according to CE certified process. In addition, the status of the Notified Bodies is regularly monitored.