Management systems and audits

At be-on-quality, we guide medical device companies through the full implementation of compliant and efficient Quality Management Systems (QMS). From initial gap assessments to full ISO 13485 certification readiness, we tailor each system to the organisation’s size, structure, and product portfolio. We support the creation of quality manuals, procedures, work instructions, and records, ensuring alignment with MDR, IVDR, and international standards. Our hands-on approach includes training, internal audits, and continuous improvement strategies. Whether you're building a QMS from scratch or optimising an existing one, we help you establish a strong foundation for regulatory compliance, operational excellence, and long-term success. Support service for coaching and executing the creation of quality manuals, procedures, work instructions, and records, ensuring alignment with MDR, IVDR, and international standards. Needs and outcomes vary between building a QMS from scratch or optimising an existing one.