Quality management systems according to ISO 13485 are the tool for optimizing processes in medical technology
ISO 13485 is the international standard for quality management systems in medical technology. It forms the basis for the safe and compliant development, manufacture, and maintenance of medical devices.
Our experts accompany you from the initial analysis to successful certification:
- Implementation of customized processes As part of the project, a robust quality management system (QMS) is established that covers all requirements of the international ISO 13485 standard.
- Standardized procedures are used in risk management and process control to minimize sources of error and increase product safety.
- Continuous improvement: Regular audits and optimizations serve to meet constantly changing regulatory requirements.
Take advantage of our expertise to make your products safe, efficient, and internationally marketable – with a QMS that meets the highest standards.