02 beo en qm

Quality Management System

Quality Management System (QMS) is one of the greatest challenges in the medical device industry today. Certain manufacturers are legally required to work according to a certified QMS (ISO 9001 / ISO 13485). For others, it is simply a measure to indicate reliable, high-quality service. The implementation of QMS is definitely an advantage: customer satisfaction and a certificate confirm well-defined and well-organized processes.

For the QM certificate, the implementation of a custom-made QM-system is required, which needs manufacturer-specific solutions and not mass-produced instructions. Our team, experienced in the medical-device industry and with understanding of medical-device producers’ needs, is ready to assist you with the entire QMS setup and certification.

Our Services

  • QM-system based on the ISO 9000 series and ISO 13485
  • Company structure and system analysis
  • Company-specific solution definition
  • QM-system development and implementation
  • Employee training
  • Internal auditing
  • External audit supervision
  • QM-system maintenance


Please ask for a non-binding offer via our Contact Form.