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.
- 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.