Electronic quality management system (eQMS)

An eQMS provides a structured, traceable environment for creating, reviewing and approving the documentation required to develop safe and effective medical devices. It ensures that all quality-related information is complete, controlled and audit-ready. For manufacturers operating under MDR, IVDR or FDA regulations, an eQMS is not only a best practice but also a legal necessity.

Structured content enhances the effectiveness of an eQMS by giving teams granular control over their documentation. Instead of editing entire documents, medical writers manage reusable content components that can be updated once and propagated wherever they appear. This reduces rework, improves consistency and ensures that content submitted to the eQMS reflects the latest approved version. When integrated with an eQMS, Tridion Docs helps organizations streamline authoring, maintain accurate versions and publish final outputs directly into the quality system. This creates a seamless connection between the content creation environment and the controlled document repository. RWS supports regulated organizations through structured content practices that strengthen accuracy, traceability and compliance across the entire product lifecycle.

RWS enables more efficient and compliant eQMS workflows through Tridion Docs, where structured content supports granular version control, consistent terminology and faster updates. By combining expert guidance with intelligent technology, organizations can connect their authoring environment directly to the eQMS, ensuring every document is accurate, traceable and ready for regulatory review.