Montrium Connect has been developed with medical device companies in mind. We are able to manage all documents and records both during the R&D and commercial phases in one central location. Predefined configurations for DHFs, DMRs and DHRs allow you to quickly start to author, collaborate and manage all documents and records. Because our solution is web-based, it is possible to work across geographically diverse teams to ensure that everyone is working on the latest version.
Meeting the requirements of ISO 13485 can be challenging and Montrium Connect has been conceived to facilitate the implementation of ISO compliant quality systems. Our quality modules integrate to provide a comprehensive solution which allows you to proactively manage quality both internally and with suppliers. All quality events can be centrally registered and then resolved in a timely manner. Metrics and KPIs give you real-time indicators on the health of your operations and the ability to proactively act on quality trends.