Approval and monitoring authorities require documented quality management from the development process to series production, parallel to the certified product itself. The high dynamics of extending and supplementing existing standards is a challenge that ERGOSURG has successfully mastered. Risk management, lifelong product monitoring and traceability are terms ERGOSURG takes for granted when the focus is on safeguarding the health of users and patients.
ERGOSURG supports the entire development process efficiently and successfully with an accompanying documentation system in order to be able to offer cost-effective continuous documentation.
Of course, our processes are EN ISO 13485 certified and we work according to ISO 9001.