Surveillance audit for ISO 9001 & ISO 13485 successfully completed in March

Our second surveillance audit for ISO 9001 and ISO 13485 took place in March. As part of this, we had two auditors from our notified body MDC (Medical Device Certification) on site for two days.

During the audit, various areas of our company were thoroughly examined, including management, our quality management system, our production facility, and product development. The audit focused on the following areas:

  • Management: Responsibility, resources, and infrastructure
  • Documentation & records: Processes and their interactions
  • Customer-related processes: Determining customer requirements
  • Design and development: Risk management
  • Production & service processes: working environment, incoming goods, in-process and final inspections
  • Procurement: selection and qualification of suppliers
  • Measurement, analysis & improvement: internal audits, data analysis and improvement processes

Thanks to our high standards and consistent implementation of quality guidelines, we were able to achieve an extremely positive audit result. We are pleased to announce that we have successfully maintained our certification. This reflects our commitment to the highest quality standards and continuous improvement in all areas.