Surveillance audit according to EN ISO 13485 successfully completed

EN ISO 13485 defines requirements for quality management systems for organizations involved in the development, manufacturing and provision of medical devices or related services. The standard focuses on clearly defined processes, traceable documentation, compliance with regulatory requirements and consistent quality.

Following our successful recertification last year, this year’s surveillance audit assessed whether the requirements of the standard continue to be met and whether the defined processes are consistently implemented in our day-to-day operations. The positive result confirms the effectiveness of our quality management system.

For our customers, this means transparent workflows, traceable quality standards and reliable processes in the development and implementation of our solutions for MedTech applications.

Successfully completing the surveillance audit is also an important part of our continuous quality management activities. We regularly review and improve our processes to ensure reliable compliance with regulatory requirements and customer expectations.