Regulatory information management software (RIM/RIMS)

A Regulatory Information Management (RIM) platform is a software solution where medical device organizations can keep all their regulatory compliance assets: documents, communication with regulatory bodies, or certificates. Such software acts as a single source of truth for all communication and exchanges with regulatory authorities. It ensures everyone is working with the latest and most up-to-date information.

A RIM system allows medical device manufacturers to manage UDI information, monitor and manage product registrations, or even track laws, regulations, and standards – all to streamline the regulatory submission process.

How does structured content help?

When a RIM system is integrated with a structured content management (SCM) system, organizations benefit from a deeper layer of control over the content they create. A RIM system enables all stakeholders to work online and author collaboratively. But adding on top of the RIM capabilities, an SCM tool gives authors, reviewers, and approvers a faster way of creating documentation by enabling content reuse and quick content updates by making changes to the source content, which will propagate to all content instances.

Key benefits

• Enable faster authoring with content reuse

• Keep track of all content changes no matter how small for a 100% accurate audit trail

• Offer stakeholders an environment where they can co-author large-volume documents without freezing or crashing

• Quickly identify where a content component has been used and make rapid changes to all instances