Design Controls and Development: DMR

Automate and efficiently manage the compilation of DMR records. Save time and eliminate errors caused by existing information silos and redundant systems that manage the Device Master Record (DMR)

Increasing business, product and process complexities affect operating margins and are driving companies to find business solutions that foster innovation and improve efficiencies.

In the Life Sciences industry, the need for the development of new products 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. 

Design Controls and Development: DMR saves 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.

Automation of the compilation of the DMR (Device Master Record) efficiently ensures compliance with FDA Part 820 and greatly reduces the risk of error.  Existing information silos that manage the DMR are unified and global product teams can efficiently collaborate, approve and implement device designs, specifications and procedural changes on a common platform.