License for DMR Change
Provide a Dynamic, Data Driven Device Master Record for Full Traceability and Automated Reporting
Increasing business, product and process complexities affect operating margins and are driving companies to find business solutions which foster innovation and improve efficiencies. In the Life Sciences industry, the complexity and rate at which new products need to be developed has already out-paced the rate at which many companies can produce them. Furthermore, the rate at which companies need to develop product content is expected to continue to grow faster than the current rate of productivity improvements. License for DMR Change saves companies time and effort by eliminating redundant data entry and validation of medical device procedures and specifications with a single, centralized, secure, digital repository that helps ensure compliance with FDA regulations, ISO quality standards, and other global regulatory requirements. Automate and efficiently manage the compilation of DMR (Device Master Record) files to ensure FDA Part 820 compliance, save time and eliminate errors caused by existing information silos and redundant systems which manage the DMR, and enable global product teams to efficiently collaborate, approve and implement device designs, specifications and procedural changes through an automated change control process on a common platform.