QMS & ISO 13485
A robust Quality Management System is the foundation of regulatory compliance and operational integrity for medical device and in vitro diagnostic manufacturers. Under the MDR and IVDR, ISO 13485 has become the universal benchmark for demonstrating quality assurance throughout the design, manufacture, and post-market phases of device production. However, developing or remediating a QMS that meets regulatory expectations while remaining practical for daily operations remains a challenge for many organisations. Overly complex systems can burden resources and slow productivity, while underdeveloped frameworks expose manufacturers to findings, certification delays, and regulatory sanctions.
Our QMS and ISO 13485 consulting services deliver structured, compliant systems tailored to the size, maturity, and strategic objectives of each organisation. We begin with a comprehensive assessment of the existing quality infrastructure, evaluating alignment with ISO 13485:2016 requirements, MDR/IVDR interfaces, and related standards such as ISO 14971 for risk management. This assessment identifies strengths, deficiencies, and areas of redundancy, forming the basis for a pragmatic implementation or remediation plan.
Our approach emphasises integration and usability. We design quality management systems that support rather than constrain operations, ensuring that every procedure, record, and control adds measurable value. Core processes such as document control, design and development, supplier management, complaint handling, CAPA, and internal auditing are mapped clearly within the QMS architecture. These processes are supported by standardised templates and record structures that ensure traceability and audit readiness.
We also guide clients in aligning their QMS with MDR and IVDR expectations, including the integration of post-market surveillance, vigilance, and clinical evaluation feedback loops. This ensures that the quality system serves as the backbone for regulatory compliance and continuous improvement. Our consultants provide support for developing or refining Quality Manuals, Standard Operating Procedures, work instructions, and associated forms that reflect both regulatory precision and operational practicality.
For organisations transitioning from legacy systems, we offer comprehensive remediation programs that bring existing documentation and procedures into conformity with ISO 13485 and current regulatory standards. This includes defining process ownership, rationalising overlapping documents, and ensuring consistent cross-referencing with technical documentation and regulatory files.
Digital enablement forms an integral part of our methodology. Where appropriate, we assist in the configuration and deployment of electronic Quality Management Systems (eQMS) that provide version control, workflow automation, and training record traceability. Our goal is to deliver systems that are sustainable, scalable, and capable of withstanding both internal and external audits.
By combining regulatory rigor with operational insight, we help organisations transform quality management from a compliance obligation into a strategic advantage. Our frameworks enable consistent product quality, sustained regulatory approval, and organisational confidence in managing both routine operations and continuous improvement.
For further information on how our QMS and ISO 13485 services can strengthen your compliance foundation and operational excellence, please contact our quality and regulatory systems team.
